Look Up TYLENOL^® (acetaminophen) Products

Description/Ingredients

Each Extra Strength TYLENOL® Caplet, Cool Caplet, EZ Tab, or Rapid Release Gel contains acetaminophen 500 mg. Extra Strength TYLENOL® Adult Liquid is alcohol-free and each 15 mL (1 tablespoonful) contains 500 mg acetaminophen.

Actions

Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products.

Uses

Extra Strength TYLENOL® Geltabs, Caplets, Cool Caplets, EZ Tabs, Rapid Release Gels, or TYLENOL® Adult liquid:

• temporarily relieves minor aches and pains due to:
  headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, premenstrual and menstrual cramps
• temporarily reduces fever

Dosing

Extra Strength TYLENOL® Geltabs, Caplets, EZ Tabs, or Rapid Release Gels:

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 tablets, gelcaps, geltabs or caplets every 4 to 6 hours while symptoms last
• do not take more than 8 tablets, gelcaps, geltabs or caplets in 24 hours
• do not use for more than 10 days unless directed by a doctor

Children under 12 years

• do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Extra Strength TYLENOL® Adult Liquid:

• do not take more than directed (see overdose warning)
• use only enclosed measuring cup designed for use with this product. Do not use any other dosing device.

Adults and children 12 years and over

• take 2 tablespoons (tbsp.) or 1 oz in dose cup provided every 4 to 6 hours while symptoms last
• do not take more than 8 tablespoons (tbsp) or 4 oz in 24 hours
• do not take for more than 10 days unless directed by a doctor

Children under 12 years

• do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Warnings

Extra Strength TYLENOL® Geltabs, Caplets, Cool Caplets, EZ Tabs, Rapid Release Gels, Extra Strength TYLENOL® Liquid

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen

Stop use and ask a doctor if:

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

Extra Strength TYLENOL® Gelcaps, Geltabs, Caplets, Cool Caplets, EZ Tabs, or Rapid Release Gels:

• store between 20-25ºC (68-77ºF) (Caplet, Cool Caplets and EZ Tabs)
• store between 20-25ºC (68-77ºF). Avoid high humidity. (Geltab and Rapid Release Gel)

Extra Strength TYLENOL® Adult Liquid

• each tablespoon contains: sodium 9 mg
• store between 20-25ºC (68-77ºF)

PROFESSIONAL INFORMATION:OVERDOSAGE INFORMATION

Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N-acetylcysteine. For full prescribing information, refer to the N-acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115).

For additional emergency information, please contact your local poison control center.

Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

How Supplied

Extra Strength TYLENOL® Caplets:(colored white, imprinted "TYLENOL 500 mg") -vials of 10, and tamper-evident bottles of 24, 50, 100, 150, 225, and 325.

Cool Caplets (colored white, imprinted "TYLENOL 500 mg") 8, 24, 50, 100, 150.

Rapid Release Gels (colored red and light blue with an exposed grey band; gelcaps are imprinted with "TY 500") tamper-evident bottles of 8, 24, 50, 100, 150, 225, and 290.

EZ Tabs (colored red, imprinted "TYLENOL EZ Tabs") tamper-evident bottles of 24, 50, 100, 150, and 225.

Extra Strength TYLENOL® Adult Rapid Blast Liquid: Cherry-flavored liquid (colored red) 8 fl. oz. tamper-evident bottle with child resistant safety cap and special dosage cup.

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients:

Extra Strength TYLENOL® Caplets: carnauba wax*, castor oil*, cellulose, corn starch, FD&C red #40, hypromellose, magnesium stearate, polyethylene glycol*, sodium starch glycolate, titanium dioxide. *contains one or more of these ingredients. Cool Caplets: castor oil, cellulose, corn starch, FD&C red #40, flavors, hypromellose, magnesium stearate, sodium starch glycolate, sucralose, titanium dioxide. EZ Tabs: carnauba wax, cellulose, corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide. Geltabs: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Yellow #10, edetate calcium disodium, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hypromellose, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide. Rapid Release Gels: benzyl alcohol, black iron oxide, butylparaben, cellulose, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C red #40, gelatin, hypromellose, magnesium stearate, methylparaben, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide.

Extra Strength TYLENOL® Adult Liquid: citric acid, corn syrup, D&C red #33, FD&C red #40, flavor, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Description/Ingredients

Each Regular Strength TYLENOL® Tablet contains acetaminophen 325 mg.

Actions

Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products.

Uses

Regular Strength TYLENOL® Tablets:

• temporarily relieves minor aches and pains due to:
  headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, premenstrual and menstrual cramps
• temporarily reduces fever

Regular Strength TYLENOL® Tablets:

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 tablets every 4 to 6 hours as needed
• do not take more than 12 tablets in 24 hours
• do not use for more than 10 days unless directed by a doctor

Children 6-11 years

• take 1 tablet every 4 to 6 hours as needed
• do not take more than 5 tablets in 24 hours
• do not use for more than 5 days unless directed by a doctor

Children under 6 years

• do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of TYLENOL® and may cause liver damage

Warnings

Regular Strength TYLENOL® Tablets

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen

Stop use and ask a doctor if:

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

Regular Strength TYLENOL® Tablets

• store between 20-25ºC (68-77ºF)

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N-acetylcysteine. For full prescribing information, refer to the N-acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115)

For additional emergency information, please contact your local poison control center.

Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

How Supplied

Regular Strength TYLENOL® Tablets: (colored white, scored, imprinted "TYLENOL" and "325")-tamper-evident bottles of 100.

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients:

Regular Strength TYLENOL® Tablets: cellulose, corn starch, magnesium stearate, sodium starch glycolate.

Description/Ingredients

Each TYLENOL® Arthritis Pain Extended Release Geltab/Caplet contains acetaminophen 650 mg.

Actions

Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products. TYLENOL® Arthritis Pain Extended Release uses a unique, patented, bilayer geltab/caplet. The first layer dissolves quickly to provide prompt relief while the second layer is time released to provide up to 8 hours of relief.

Uses

TYLENOL® Arthritis Pain Extended Release Geltabs:

• temporarily relieves minor aches and pains due to:
  minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, toothache

TYLENOL® Arthritis Pain Extended Release Caplets:

• temporarily relieves minor aches and pains due to:
  arthritis, the common cold, headache, toothache, muscular aches, backache, menstrual cramps

Dosing

TYLENOL® Arthritis Pain Extended Release Geltabs/Caplets:

• do not take more than directed (see overdose warning)

Adults

• take 2 geltabs or caplets every 8 hours with water
• swallow whole - do not crush, chew or dissolve
• do not take more than 6 geltabs or caplets in 24 hours
• do not use for more than 10 days unless directed by a doctor

Under 18 years of age

• ask a doctor

Warnings

TYLENOL® Arthritis Pain Extended Release Geltabs, Caplets

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen

Stop use and ask a doctor if:

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

• store at 20-25ºC (68-77ºF)
• avoid excessive heat 40ºC (104ºF)

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N-acetylcysteine. For full prescribing information, refer to the N-acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115)

For additional emergency information, please contact your local poison control center.

Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

How Supplied

TYLENOL® Arthritis Pain Extended Release Caplets: (colored white, engraved "TYLENOL ER") tamper-evident bottles of 24, 50, 100, 150, 225 and 290

Geltabs: available in bottles of 20, 40 and 80

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients:

TYLENOL® Arthritis Pain Extended Release Caplets: carnauba wax, corn starch, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin.
Geltabs: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, FD&C Blue #1, FD&C Blue #2, gelatin, hydroxyethyl cellulose, hypromellose, magnesium stearate, methylparaben, povidone, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

Description/Ingredients

Each TYLENOL® 8 Hour Extended Release Caplet contains acetaminophen 650 mg.

Actions

Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products. TYLENOL® 8 Hour Extended Release uses a unique, patented, bilayer geltab/caplet. The first layer dissolves quickly to provide prompt relief while the second layer is time released to provide up to 8 hours of relief.

Uses

TYLENOL® 8 Hour Extended Release Caplets:

• temporarily relieves minor aches and pains due to:
  muscular aches, backache,headache, toothache, the common cold, menstrual cramps, minor pain of arthritis
• temporarily reduces fever

Dosing

TYLENOL® 8 Hour Extended Release Caplets:

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 tablets every 4 to 6 hours as needed
• do not take more than 12 tablets in 24 hours

Children 6-11 years

• take 1 tablet every 4 to 6 hours as needed
• do not take more than 5 tablets in 24 hours

Children under 6 years

• do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of TYLENOL® and may cause liver damage

Warnings

TYLENOL® 8 Hour Extended Release Caplets

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen

Stop use and ask a doctor if:

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

TYLENOL® 8 Hour Extended Release Caplets:

• store between 20-25ºC (68-77ºF)
• avoid excessive heat 40ºC (104ºF)

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N-acetylcysteine. For full prescribing information, refer to the N-acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115)

For additional emergency information, please contact your local poison control center.

Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

How Supplied

TYLENOL® 8 Hour Extended Release Caplets: (colored red, imprinted "8 hour") available in 24's, 50's, 100's, and 150's.

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients:

TYLENOL® 8 Hour Extended Release Caplets: corn starch, D&C yellow #10, FD&C red #40, FD&C yellow #6, hydroxyethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, powdered cellulose, pregelantinized starch, sodium starch glycolate, sucralose, talc, titanium dioxide.

Description/Ingredients

Each Women's TYLENOL® Menstrual Relief Caplet contains acetaminophen 500 mg and pamabrom 25 mg.

Actions

Women's TYLENOL® Menstrual Relief Caplets contain a clinically proven analgesic-antipyretic and a diuretic. Maximum allowable non-prescription levels of acetaminophen and pamabrom provide temporary relief of minor aches and pains due to cramps, headache, and backache and water retention, weight gain, bloating, swelling and full feeling associated with the premenstrual and menstrual periods. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin containing products. Acetaminophen is thought to produce analgesia by elevation of the pain threshold. Pamabrom is a diuretic which relieves water retention.

Uses

Women's TYLENOL® Menstrual Relief Caplets:

• temporarily relieves minor aches and pains due to:
  headache, backache, premenstrual and menstrual cramps, temporarily relieves water-weight gain, bloating, swelling and/or full feeling associated with the premenstrual and menstrual periods

Dosing

Women's TYLENOL® Menstrual Relief Caplets:

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 caplets every 4 to 6 hours
• do not take more than 8 caplets in 24 hours

Children under 12 years

• do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Warnings

Women's TYLENOL® Menstrual Relief Caplets:

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen

Stop use and ask a doctor if:

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

Women's TYLENOL® Menstrual Relief Caplets:

• store between 20-25ºC (68-77ºF)

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N-acetylcysteine. For full prescribing information, refer to the N-acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115)

For additional emergency information, please contact your local poison control center.

Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

How Supplied

Women's TYLENOL® Menstrual Relief Caplets: White capsule shaped caplets with TYME printed on one side in tamper-evident bottles of 24.

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients:

Women's TYLENOL® Menstrual Relief Caplets: cellulose, corn starch, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, triacetin

Description/Ingredients

Each TYLENOL® Allergy Multi-Symptom Caplet with Cool Burst™ and Gelcap contains acetaminophen 325 mg, chlorpheniramine maleate 2 mg, and phenylephrine HCl 5 mg.

Actions

TYLENOL® Allergy Multi-Symptom Caplets with Cool Burst™ and Gelcaps contain, in addition to acetaminophen, a decongestant, phenylephrine HCl and an antihistamine, chlorpheniramine maleate. Phenylephrine HCl is a sympathomimetic amine which provides temporary relief of nasal and sinus congestion. Chlorpheniramine is an antihistamine which helps provide temporary relief of runny nose, sneezing and watery and itchy eyes.

Uses

TYLENOL® Allergy Multi-Symptom Caplets with Cool Burst™:

• temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  headache, sinus congestion and pressure, nasal congestion, runny nose and sneezing, minor aches and pains

• temporarily relieves these additional symptoms of hay fever:
  itching of the nose or throat, itchy, watery eyes
• helps clear nasal passages

TYLENOL® Allergy Multi-Symptom Gelcaps:

• temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  minor aches and pains, headache, nasal congestion, runny nose and sneezing, sinus congestion and pressure, itching of the nose or throat, itchy, watery eyes
• helps clear nasal passages

Dosing

TYLENOL® Allergy Multi-Symptom Caplets with Cool Burst™ and Gelcaps:

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 caplets or gelcaps every 4 hours
• swallow whole - do not crush, chew or dissolve (caplets only)
• do not take more than 12 caplets or gelcaps in 24 hours

Children under 12 years

• do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Warnings

TYLENOL® Allergy Multi-Symptom Caplets with Cool Burst™ and Gelcaps:

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product:

• do not exceed recommended dosage
• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

TYLENOL® Allergy Multi-Symptom Caplets with Cool Burst™:

• store between 20-25ºC (68-77ºF)
• store between 20-25ºC (68-77ºF). Avoid high humidity.

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N-acetylcysteine. For full prescribing information, refer to the N-acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N-acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115)

Our adult TYLENOL® combination products contain active ingredients in addition to acetaminophen. The following is basic overdose information regarding those ingredients.

Chlorpheniramine: Chlorpheniramine toxicity should be treated as you would an anthihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.

Phenylephrine: Symptoms from phenylephrine overdose most often consist of hypertension, anxiety, nervousness, restlessness, tachycardia, bradycardia, headache, dizziness, and/or palpitations. Symptoms usually are transient and typically require no treatment.

For additional emergency information, please contact your local poison control center.

Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

How Supplied

TYLENOL® Allergy Multi-Symptom:

Caplets with Cool Burst™: Off-white, imprinted with "TY C1076" - blister packs of 24 and 48.

Gelcaps: yellow/green, imprinted with "TY C1077" - blister packs of 24.

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients:

TYLENOL® Allergy Multi-Symptom Caplets with Cool Burst™: Caplets with Cool Burst™: anhydrous citric acid, colloidal silicon dioxide^*, corn starch, flavors, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, stearic acid ^*, sucralose, titanium dioxide, yellow iron oxide.
Gelcaps: benzyl alcohol, butylparaben, castor oil, colloidal silicon dioxide, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, stearic acid, titanium dioxide

*may contain one or more of these ingredients