The new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. There may be a period of time during which both labels may be on the store shelves. Your patients can continue to use their Extra Strength TYLENOL® products as labeled.

Mechanism of Action

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.

The new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. There may be a period of time during which both labels may be on the store shelves. Your patients can continue to use their Extra Strength TYLENOL® products as labeled.

Uses

Extra Strength TYLENOL® Caplets, EZ Tabs, Rapid Release Gels, or TYLENOL® Adult Rapid Blast Liquid:

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

Dosing

Extra Strength TYLENOL® 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 caplets every 6 hours while symptoms last
• do not take more than 6 caplets in 24 hours, unless directed by a doctor
• do not use for more than 10 days unless directed by a doctor

Children under 12 years

• ask a doctor

Extra Strength TYLENOL® Adult Rapid Blast 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 30 mL (2 TBSP) (1 FL OZ) in the dosing cup provided every 6 hours while symptoms last
• do not take more than 90 mL (6 TBSP) (3 FL OZ) in 24 hours, unless directed by a doctor
• do not use for more than 10 days unless directed by a doctor

Children under 12 years

• ask a doctor

The new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. There may be a period of time during which both labels may be on the store shelves. Your patients can continue to use their Extra Strength TYLENOL® products as labeled.

Warnings

Extra Strength TYLENOL® Caplets, EZ Tabs, Rapid Release Gels, Extra Strength TYLENOL® Adult Rapid Blast Liquid

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts 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:

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

• store between 20-25ºC (68-77ºF) (Caplet and EZ Tab)
• store between 20-25ºC (68-77ºF). Avoid high humidity. (Rapid Release Gel)

Extra Strength TYLENOL® Adult Rapid Blast Liquid:

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

The new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. There may be a period of time during which both labels may be on the store shelves. Your patients can continue to use their Extra Strength TYLENOL® products as labeled.

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.
(1-800-222-1222). 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.

The new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. There may be a period of time during which both labels may be on the store shelves. Your patients can continue to use their Extra Strength TYLENOL® products as labeled.

How Supplied

Extra Strength TYLENOL® Caplets

EZ Tabs

Rapid Release Gels

Extra Strength TYLENOL® Adult Rapid Blast Liquid

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

The new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. There may be a period of time during which both labels may be on the store shelves. Your patients can continue to use their Extra Strength TYLENOL® products as labeled.

Inactive Ingredients

Extra Strength TYLENOL® Caplets: carnauba wax*, castor oil*, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide. *contains one or more of these ingredients.

EZ Tabs: anhydrous citric acid, carnauba wax, 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, potassium sorbate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, talc, titanium dioxide.

Rapid Release Gels: benzyl alcohol, butylparaben, carboxymethylcellulose sodium, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C red #40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide.

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