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Maximum strength tylenol allergy sinus day time caplets, gelcaps, and geltabs

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 Maximum Strength TYLENOL Allergy Sinus Night Time Caplet contains acetaminophen 500 mg, diphenhydramine HCl 25 mg, and pseudoephedrine HCl 30 mg. Each Maximum Strength TYLENOL Allergy Sinus Day Time Caplet Gelcap and Geltab 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.

Maximum Strength TYLENOL Allergy Sinus 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.

Maximum Strength TYLENOL Allergy Sinus Day Time Caplets, Gelcaps and Geltabs 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

Maximum Strength TYLENOL Allergy Sinus Night Time and TYLENOL Allergy Sinus Day Time: 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)

adults and children
12 years and over
· take 2 caplets every 4 to 6 hours as needed
· 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.

Maximum Strength TYLENOL Allergy Sinus Night Time:

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

adults and children
12 years and over
· take 2 caplets every 4 to 6 hours as needed
· 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.

Maximum Strength TYLENOL Allergy Sinus Day Time:

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

adults and children
12 years and over
· take two caplets, gelcaps, or geltabs every 4 to 6 hours as needed
· do not take more than 8 caplets, gelcaps, or geltabs 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 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 Sinus Day Time)

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

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.

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur (does not apply to TYLENOL Allergy Sinus Day Time)
  • drowsiness may occur (applies to TYLENOL Allergy Sinus Day Time 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

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

Maximum Strength TYLENOL Allergy Sinus Night Time and Maximum Strength TYLENOL Allergy Sinus Day Time

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

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 Sinus Day Time Caplet and TYLENOL Allergy Sinus Night Time Caplet:

  • store at room temperature

TYLENOL Allergy Sinus Day Time Gelcap & Geltabs

  • store at room temperature. Avoid high humidity and excessive heat 40°C (104°F)

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.

Maximum Strength TYLENOL Allergy Sinus 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.

Maximum Strength TYLENOL Allergy Sinus Day Time: Caplets: carnauba wax, cellulose, corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide. Gelcaps and Geltabs: 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.

Maximum Strength TYLENOL Allergy Sinus Night Time: Caplets: Light blue film-coated, imprinted with "TYLENOL A/S Night Time" on one side--blister packs of 24.

Maximum Strength TYLENOL Allergy Sinus Day Time: Caplets: Yellow film-coated, imprinted with "TYLENOL Allergy Sinus" on one side--blister packs of 24.

Gelcaps and Geltabs: 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 Maximum Strength Tylenol Allergy Sinus Day (pack of 12) and Maximum Strength Tylenol Allergy Sinus Night (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. 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.
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