Product information for all dosage forms of TYLENOL Cold have been combined under this heading.

DESCRIPTION

Each Multi-Symptom TYLENOL® Cold Day Non-Drowsy Caplet with Cool Burst™ and Gelcap contains acetaminophen 325 mg, dextromethorphan HBr 15 mg, and pseudoephedrine HCl 30 mg.

Each Multi-Symptom TYLENOL® Cold Night Time with Cool Burst™ Caplet contains acetaminophen 325 mg, chlorpheniramine maleate 2 mg, dextromethorphan HBr 15 mg, and pseudoephedrine HCl 30 mg.

ACTIONS

TYLENOL® Cold Day Non-Drowsy contains a clinically proven analgesic-antipyretic, a decongestant and a 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 it 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. 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 Night Time contains, in addition to the above ingredients, an antihistamine. Chlorpheniramine is an antihistamine which helps provide temporary relief of runny nose, sneezing and watery and itchy eyes.

USES

TYLENOL® Cold Day Non-Drowsy: temporarily relieves these cold symptoms:

· cough · sore throat · minor aches and pains · headaches · nasal congestion

· temporarily reduces fever

TYLENOL® Cold Night Time: temporarily relieves these cold symptoms:

· cough · sore throat · minor aches and pains · headache · nasal congestion · runny nose · sneezing · watery and itchy eyes

· temporarily reduces fever

DIRECTIONS

TYLENOL® Cold Day Non-Drowsy Gelcaps

do not take more than directed (see overdose warning)


adults and children 12 years and over	·take 2 gelcaps every 6 hours as needed ·do not take more than 8 gelcaps in 24 hours.
children under 12 years	·not intended for use in children under 12. Ask your doctor.

TYLENOL® Cold Day Non-Drowsy and Night 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	·not intended for use in children under 12. Ask your doctor.

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

TYLENOL® Cold Day Non-Drowsy

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

TYLENOL® Cold Night Time:

Ask a doctor before use if you have

· heart disease · glaucoma · diabetes · thyroid disease

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

· do not exceed recommended dosage

· drowsiness may occur · avoid alcoholic drinks
· alcohol, sedatives and tranquilizers may increase drowsiness · be careful when driving a motor vehicle or operating machinery · excitability may occur, especially in children

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 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 between 20-25°C (68-77°F)
store at room temperature; avoid high humidity and excessive heat 40°C (104°F) (Applies to TYLENOL® Cold Non-Drowsy Gelcap only)
See side panel for lot number and expiration date

PROFESSIONAL INFORMATION:
OVERDOSAGE INFORMATION

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

Inactive Ingredients:

TYLENOL® Cold Day Non Drowsy Formula: Caplets: carnauba wax, cellulose, corn starch, FD&C blue #1 flavor, hypromellose, magnesium stearate, mannitol, sodium starch glycolate, sucralose, titanium dioxide.

Gelcaps : benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Yellow #10, edetate calcium disodium, FD&C Red #40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

TYLENOL® Cold Night Time: Caplets: carnauba wax, castor oil, cellulose, corn starch, FD&C blue #1, flavor hypromellose, magnesium stearate, mannitol, sodium starch glycolate, sucralose, titanium dioxide.

HOW SUPPLIED

TYLENOL® Cold Day Non Drowsy Caplets: White-colored, imprinted with "TYLENOL Cold"--blister packs of 12 & 24. Gelcaps: Red- and tan-colored, imprinted with "TYLENOL COLD"--blister packs of 24.

TYLENOL® Cold Night Time Caplets: Yellow-colored, imprinted with "TYLENOL Cold"--blister packs of 12 & 24.

These products are also available in a convenience pack containing TYLENOL® Cold Day Non-Drowsy Caplet (pack of 12) and TYLENOL® Cold Night Time Caplet (pack of 12).

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.