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TYLENOL® Cold Severe Congestion Daytime Caplets with Cool Burst™ contain a clinically proven analgesic-antipyretic, decongestant, expectorant and 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 is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products. Pseudoephedrine is a sympathomimetic amine which provides temporary relief of nasal congestion. Guaifenesin is an expectorant which helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. Dextromethorphan is a cough suppressant which provides temporary relief of coughs due to minor throat irritations that may occur with the common cold.

Uses

TYLENOL® Cold Severe Congestion Daytime Caplets with Cool Burst™:

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

Dosing

TYLENOL® Cold Severe Congestion Daytime Caplets with Cool Burst™:

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

Adults and children 12 years and over

• take 2 caplets every 6 hours as needed
• swallow whole - do not crush, chew or dissolve
• 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

TYLENOL® Cold Severe Congestion Daytime Caplets with Cool 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 ocurrs with smoking, asthma, chronic bronchitis, or emphysema
• cough that ocurrs with too much phlegm (mucus)

When using this product:

• do not exceed recommended dosage

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 Severe Congestion Daytime Caplets with Cool Burst™

• each caplet contains: sodium 3 mg
• store between 20-25°C (68-77°F)

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.

Dextromethorhphan: Acute dextromethorphan overdose usually does not result in serious signs and symptoms unless massive amounts have been ingested. Signs and symptoms of a substantial overdose may include nausea and vomiting, visual disturbances, CNS disturbances and urinary retention.

Guaifenesin: Guaifenesin should be treated as a nontoxic 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® Cold Severe Congestion Daytime Caplets with Cool Burst™: Caplets: Yellow-colored, imprinted with "TYLENOL COLD SC" in green ink-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® Cold Severe Congestion Daytime Caplets with Cool Burst™: carnauba wax, cellulose, corn starch, croscarmellose sodium, FD&C blue #1, flavor, hypromellose, mannitol, povidone, silicon dioxide, stearic acid, sucralose, titanium dioxide