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TYLENOL® Cold Multi-Symptom Daytime Caplets with Cool Burst™ and Gelcaps contain a clinically proven analgesic/antipyretic, a decongestant and a cough suppressant. 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. Phenylephrine hydrochloride is a sympathomimetic amine which provides temporary relief of nasal congestion. Dextromethorphan is a cough suppressant which provides temporary relief of coughs due to minor throat irritations that may occur with the common cold.

TYLENOL® Cold Multi-Symptom Severe Caplets with Cool Burst™ contain the same clinically proven analgesic/antipyretic, decongestant and cough suppressant as TYLENOL® Cold Multi-Symptom Caplets with Cool Burst™ and Gelcaps along with an expectorant. Guaifenesin is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

TYLENOL® Cold Multi-Symptom Severe Daytime Liquid with Citrus Burst contains the same clinically proven analgesic/antipyretic, cough suppressant, expectorant and decongestant as TYLENOL® Cold Multi-Symptom Severe Caplets with Cool Burst™.

Uses

TYLENOL® Cold Multi-Symptom Severe Caplets with Cool Burst™:

• temporarily relieves these common cold symptoms:
  minor aches and pains, headache, sore throat, nasal congestion, cough, impulse to cough
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever

TYLENOL® Cold Multi-Symptom Severe Daytime Liquid with Citrus Burst:

• for the temporary relief of the following cold symptoms:
  minor aches and pains, headache, sore throat, nasal congestion, cough, impulse to cough
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever

Dosing

TYLENOL® Cold Multi-Symptom Severe Caplets with Cool Burst™:

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

Adults and children 12 years and over

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

TYLENOL® Cold Multi-Symptom Severe Daytime Liquid with Citrus Burst:

• 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 every 4 hours
• do not take more than 12 tablespoons (tbsp) or 6 oz 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® Cold Multi-Symptom Severe Caplets with Cool Burst™
TYLENOL® Cold Multi-Symptom Severe Daytime Liquid with Citrus Burst

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

When using this product:

• do not exceed recommended dosage (all products)

Stop use and ask a doctor if:

• nervousness, dizziness, or sleeplessness occurs
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts

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® Cold Multi-Symptom Severe Caplets with Cool Burst™

• each caplet contains: sodium 3 mg

TYLENOL® Cold Multi-Symptom Severe Daytime Liquid

• each tablespoon contains: sodium 5 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

TYLENOL® Cold Multi-Symptom Severe Caplets with Cool Burst™: yellow, imprinted with "TY MS C1071" - blister packs of 24.

TYLENOL® Cold Multi-Symptom Severe Daytime Liquid: Citrus Burst Liquid, orange colored - bottles of 8 fl. Oz.

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® Cold Multi-Symptom Severe Caplets with Cool Burst™:

carnauba wax, cellulose, corn starch, croscarmellose sodium, D&C yellow #10, flavors, hydroxypropyl cellulose, hypromellose, iron oxide, mannitol, silicon dioxide, stearic acid, sucralose

TYLENOL® Cold Multi-Symptom Severe Daytime Liquid with Citrus Burst:

citric acid, ethyl alcohol, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose