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Tylenol Cold & Flu Severe Daytime Liquid with Cool Bust, Tylenol Flu NightTime Gelcaps, Tylenol Flu Day Non-Drowsy Gelcaps, Tylenol Cold & Flu Severe NightTime Liquid with Cool Burst (McNeil Consumer)



  • Description
  • Clinical Pharmacology
  • Indications and Usage
  • Dosage and Administration
  • Warnings
  • Overdosage
  • Description (2)
  • How Supplied



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

    DESCRIPTION

    Each TYLENOL® Flu Day Non-Drowsy Gelcap contains acetaminophen 500 mg, dextromethorphan HBr 15 mg and pseudoephedrine HCl 30 mg. Each TYLENOL® Flu NightTime Gelcap contains acetaminophen 500 mg, diphenhydramine HCl 25 mg and pseudoephedrine HCl 30 mg. TYLENOL® Cold & Flu Severe NightTime Liquid with Cool Burst™: Each 15 mL (1 tablespoon) contains acetaminophen 500 mg, dextromethorphan HBr 15 mg, doxylamine succinate 6.25 mg, and pseudoephedrine HCl 30 mg. TYLENOL Cold & Flu Severe Daytime Liquid with Cool Burst™:    Each 15 mL (1 tablespoon) contains acetaminophen 500 mg, dextromethorphan HBr 15 mg, pseudoephedrine HCl 30 mg.

    ACTIONS

    TYLENOL® Flu Day Non-Drowsy Gelcaps contain 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 hydrochloride 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® Flu NightTime Gelcaps contains the same clinically proven analgesic-antipyretic and decongestant as TYLENOL Flu Day Non-Drowsy Gelcaps along with an antihistamine. Diphenhydramine is an antihistamine which helps provide temporary relief of runny nose and sneezing. TYLENOL Cold & Flu Severe Daytime Liquid with Cool Burst™ contains the same clinically proven analgesic - antipyretic, decongestant and cough suppressant as TYLENOL Flu Day Non-Drowsy Gelcaps . TYLENOL® Cold & Flu Severe NightTime Liquid with Cool Burst™ contains the same clinically proven analgesic-antipyretic, decongestant and cough suppressant as TYLENOL Flu Day Non-Drowsy Gelcaps along with an antihistamine. Doxylamine succinate is an antihistamine which helps provide temporary relief of runny nose and sneezing.

    USES

    TYLENOL® Flu Day Non-Drowsy Gelcaps:

    temporarily relieves these cold and flu symptoms:

    • minor aches and pains · headaches
    • sore throat · nasal congestion
    • coughs
    • temporarily reduces fever

    TYLENOL® Flu NightTime Gelcaps:

    temporarily relieves these cold and flu symptoms:

    • minor aches and pains · headaches
    • sore throat · nasal congestion · runny nose · sneezing
    • temporarily reduces fever

    TYLENOL® Cold & Flu Severe Daytime Liquid with Cool Burst™:

    temporarily relieves:

    • minor aches and pains · headache · cough
    • nasal congestion · sore throat
    • temporarily reduces fever

    TYLENOL® Cold & Flu Severe Nighttime Liquid with Cool Burst™:

    temporarily relieves these cold and flu symptoms:

    • body aches and headaches · cough · nasal congestion
    • sore throat · runny nose · sneezing
    • temporarily reduces fever

    DIRECTIONS

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

    TYLENOL® Flu Day Non-Drowsy Gelcaps:

    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 ·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.

    TYLENOL® Flu NightTime Gelcaps:

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

    adults and children 12 years and over ·take 2 gelcaps at bedtime
    ·may repeat every 6 hours
    ·do not take more than 8 gelcaps 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.

    TYLENOL® Cold & Flu Severe Daytime Liquid with Cool Burst™:

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

    adults and children 12 years and over ·take 2 tablespoons (tbsp) every 6 hours as needed using measuring cup
    ·do not take more than 8 tablespoons 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.

    TYLENOL® Cold & Flu Severe Nighttime Liquid with Cool Burst™:

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

    adults and children 12 years and over ·take 2 tablespoons (tbsp) in dose cup provided every 6 hours as needed
    ·do not take more than 8 tablespoons 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
    • with any other product containing diphenhydramine, even one used on skin (applies to TYLENOL Flu NightTime Gelcaps )

    TYLENOL® Flu Day Non-Drowsy Gelcaps

    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

    • 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
    • cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

    TYLENOL® Flu NightTime Gelcaps

    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
    • marked 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

    • 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

    TYLENOL® Cold & Flu Severe Daytime Liquid with Cool Burst™

    Ask a doctor before use if you have

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

    When using this product

    • do not exceed recommended dosage

    Stop use and ask a doctor if

    • pain, cough or nasal congestion 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
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

    TYLENOL® Cold & Flu Severe Nighttime Liquid with Cool Burst™:

    Ask a doctor before use if you have

    • heart disease · glaucoma · diabetes · thyroid disease
    • cough that occurs with too much plegm (mucus)
    • high blood pressure · a breathing problem or chronic cough such 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
      • marked 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

    • 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
    • cough lasts more than 7 days, comes back or occurs with fever, 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:

    TYLENOL® Flu Day Non-Drowsy Gelcaps and TYLENOL® Flu Nighttime Gelcaps:

    • do not use if carton is opened or if blister unit is broken
    • store at room temperature; avoid high humidity and excessive heat 40°C (104°F)
    • see side panel for lot number and expiration date

    TYLENOL® Cold & Flu Severe Daytime and Nighttime Liquid with Cool Burst™:

    • each tablespoon contains: sodium 11 mg
    • do not use if dose cup seal, neck band or foil inner seal imprinted "Safety Seal®" is broken or missing
    • Store between 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:    TYLENOL® Flu Day Non-Drowsy Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

    TYLENOL® Flu NightTime Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Red #28, edetate calcium disodium, FD&C Blue #1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

    Tylenol Cold & Flu Severe Daytime Liquid with Cool Burst™: citric acid, FD&C blue #1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethyl cellulose, sorbitol, sucralose, sucrose

    Tylenol Cold & Flu Severe NightTime Liquid with Cool Burst™: citric acid, corn syrup, D&C red #33, FD&C red #40, flavors, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

    HOW SUPPLIED

    TYLENOL® Flu Day Non-Drowsy Gelcaps: Burgundy- and white-colored gelcap, imprinted with "TYLENOL FLU" in gray ink--blister packs of 12 & 24. Liquid: Blue-colored--bottles of 8 fl oz with child resistant safety cap and tamper evident packaging.

    TYLENOL® Flu NightTime: Gelcaps: Blue and white-colored gelcap, imprinted with "TYLENOL FLU NT" gray ink--blister packs of 12 and 24.

    These products are also available in a convenience pack containing TYLENOL Flu Day (pack of 12) and TYLENOL Flu Night (pack of 12).

    Tylenol Cold & Flu Severe NightTime and Daytime Liquid with Cool Burst™:

    Blue colored - bottles of 8 fl. oz with child resistant safety cap and tamper evident packaging








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    This page was last modified 30-JUN-07
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