DESCRIPTION

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

ACTIONS

TYLENOL® Cold Severe Congestion Non-Drowsy Caplets with Cool Burst™ contain 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

temporarily relieves these 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

DIRECTIONS

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, 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

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.

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

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.
with any other product containing acetaminophen

Ask a doctor before use if you have

heart disease · diabetes · thyroid disease · cough that occurs with too much phlegm (mucus) · high blood pressure · trouble urinating due to an enlarged prostate gland · chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

pain, nasal congestion or cough 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
you get nervous, dizzy or sleepless
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

do not use if carton is opened or if blister unit is broken
Store at 20-25°C (68-77°F)

See side panel for lot number and expiration date.

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

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

Inactive Ingredients: carnauba wax, cellulose, corn starch, croscamellose sodium, FD&C Blue #1 flavor, hypromellose, mannitol, povidone, silicon dioxide, stearic acid, sucralose, titanium dioxide

HOW SUPPLIED

Caplets: White-colored, imprinted with "TYLENOL COLD SC" in blue ink--blister packs of 24 & 48 ct.

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's identity should be verified by chemical analysis.