DESCRIPTION

Each Multi-Symptom TYLENOL® Cold Severe Congestion Non-Drowsy Caplet contains acetaminophen 325 mg, dextromethorphan HBr 15 mg, guaifenesin 200 mg and pseudoephedrine HCl 30 mg.

ACTIONS

Multi-Symptom TYLENOL® Cold Severe Congestion Non-Drowsy Caplets contains a clinically proven analgesic-antipyretic, decongestant, expectorant and cough suppressant. Acetaminophen produces 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

Multi-Symptom TYLENOL® Cold Severe Congestion Non-Drowsy Caplets: For the temporary relief of these cold symptoms: minor aches and pains, headaches, sore throat, nasal congestion, chest congestion, cough. For the reduction of fever.

DIRECTIONS

Adults and children 12 years of age and older:   Take 2 caplets every 6-8 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor. Children 6-11 years of age: Take 1 caplet every 6-8 hours. Do not take more than 4 caplets in 24 hours, or as directed by a doctor. Children under 6 years of age:   Do not use this product in children under 6 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems.

PRECAUTIONS

If a rare sensitivity reaction occurs, the drug should be discontinued.

WARNINGS

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

Do not use if carton is opened or if blister unit is broken.   Do not take for pain for more than 7 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists, or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 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. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a doctor or poison control center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Do not use with other products containing acetaminophen.

Drug Interaction Precaution

Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson' disease), or for 2 weeks after stoppping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

Professional Information:

Overdosage Information

For overdosage information, please refer to pgs. __ - __.

INACTIVE INGREDIENTS

Carnauba Wax, Cellulose, Corn Starch, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Hydroxypropyl Methylcellulose, Iron Oxide, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, Triacetin.

HOW SUPPLIED

Caplets:   Buttery-tan-colored, imprinted with "TYLENOL COLD SC" in green ink--blister packs of 24. Store at room temperature. Avoid high humidity and excessive heat (40°C).

PRODUCT PHOTO(S):

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

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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