Tylenol Cold Day Non-Drowsy Caplets with Cool Burst and Gelcaps (McNeil Consumer)

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

Description:    Each 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 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 contain, 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)

TYLENOL® Cold Day Non-Drowsy and Night Caplets with Cool Burst™

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

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• 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.

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

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

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 (pack of 12) and TYLENOL® Cold Night Time (pack of 12).

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