Tylenol Allergy Complete Multi-Symptom Caplets and Gelcaps with Cool Burst, Tylenol Severe Allergy Caplets, Tylenol Allergy Complete Night Time Caplets (McNeil Consumer)

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

DESCRIPTION

Each TYLENOL® Severe Allergy Caplet contains acetaminophen 500 mg and diphenhydramine HCl 12.5 mg. Each TYLENOL® Allergy Complete Night Time Caplet contains acetaminophen 500 mg, diphenhydramine HCl 25 mg, and pseudoephedrine HCl 30 mg. Each TYLENOL® Allergy Complete Multi-Symptom Caplet with Cool Burst™ and Gelcap contains acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine HCl 30 mg.

ACTIONS

TYLENOL® Severe Allergy Caplets contain a clinically proven analgesic-antipyretic and antihistamine. 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.

Diphenhydramine HCl is an antihistamine which helps provide temporary relief of itchy, watery eyes, runny nose, sneezing, itching of the nose or throat due to hay fever or other respiratory allergies.

TYLENOL® Allergy Complete Night Time Caplets contain, in addition to the above ingredients, a decongestant, pseudoephedrine HCl. Pseudoephedrine is a sympathomimetic amine which provides temporary relief of nasal and sinus congestion.

TYLENOL® Allergy Complete Multi-Symptom Caplets with Cool Burst™ and Gelcaps contain acetaminophen, pseudoephedrine HCl and the antihistamine, chlorpheniramine maleate. Chlorpheniramine is an antihistamine which helps provide temporary relief of runny nose, sneezing and watery and itchy eyes.

USES

TYLENOL® Severe Allergy: temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

· itchy, watery eyes · runny nose

· sneezing · sore throat

· itching of nose or throat

TYLENOL® Allergy Complete Night Time and TYLENOL® Allergy Complete Multi-Symptom: temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

· nasal congestion · sinus pressure

· sinus pain · headache

· runny nose · sneezing

· itchy, watery eyes · itchy throat

DIRECTIONS

TYLENOL® Severe Allergy:

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

TYLENOL® Allergy Complete Night Time:

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

TYLENOL® Allergy Complete Multi-Symptom Caplets with Cool Burst™ and Gelcaps:

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

WARNINGS

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether your 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. (applies to TYLENOL® Severe Allergy only)

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 (does not apply to TYLENOL® Severe Allergy )
• with any other product containing acetaminophen
• with any other product containing diphenhydramine, even one used on skin. (does not apply to TYLENOL® Allergy Complete Multi-Symptom)

TYLENOL® Severe Allergy

Ask a doctor before use if you have

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

TYLENOL® Allergy Complete Night Time and TYLENOL® Allergy Complete Multi-Symptom

Ask a doctor before use if you have

• heart disease · glaucoma · diabetes
• thyroid disease · high blood pressure
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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

When using this product

• do not exceed recommended dosage (see overdose warning)
• marked drowsiness may occur (does not apply to TYLENOL® Allergy Complete Multi-Symptom)
• drowsiness may occur (applies to TYLENOL® Allergy Complete Multi-Symptom only)
• 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

• new symptoms occur
• redness or swelling is present
• pain 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 (does not apply to TYLENOL® Severe Allergy)

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

TYLENOL® Severe Allergy Caplets:

• store between 20-25°C (68-77°F)

TYLENOL® Allergy Complete Multi-Symptom Caplet with Cool Burst™ and TYLENOL® Allergy Complete Night Time Caplet:

• store between 20-25°C (68-77°F)

TYLENOL® Allergy Complete Multi-Symptom Gelcap & Geltabs

• store between 20-25°C (68-77°F). Avoid high humidity
• see side panel for lot number and expiration date (for all products)

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

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

Inactive Ingredients:

TYLENOL® Severe Allergy: Caplets: carnauba wax, cellulose, corn starch, D&C Yellow #10, FD&C Yellow #6, hydroxpropyl cellulose, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, sodium citrate, sodium starch glycolate, titanium dioxide.

TYLENOL® Allergy Complete Night Time: Caplets: carnauba wax, cellulose, corn starch, D&C Yellow #10, FD&C Blue #1, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate 80, sodium citrate, sodium starch glycolate, titanium dioxide.

TYLENOL® Allergy Complete Multi-Symptom: Caplets with Cool Burst™: carnauba wax, cellulose, corn starch, flavor, hypromellose, magnesium stearate, mannitol, sodium starch glycolate, sucralose. Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Yellow #10, edetate calcium disodium, FD&C Blue #1, FD&C Blue #2, gelatin, hypromellose, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

HOW SUPPLIED

TYLENOL® Severe Allergy: Caplets: Yellow film-coated, imprinted with "TYLENOL Severe Allergy" on one side--blister packs of 24.

TYLENOL® Allergy Complete Night Time: Caplets: blue film-coated, imprinted with "TYLENOL A/C Night Time" on one side--blister packs of 24.

TYLENOL® Allergy Complete Multi-Symptom: Caplets with Cool Burst™: white film-coated, imprinted with "TYLENOL Allergy Complete" on one side--blister packs of 24.

Gelcaps: Green and yellow-colored, imprinted with "TYLENOL A/S"--blister packs of 24 and 48.

These products are also available in a convenience pack containing Tylenol Allergy Complete Multi-Symptom (pack of 12) and Tylenol Allergy Complete Night (pack of 12).

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