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Tylenol Cold Severe Congestion Non-Drowsy Caplets with Cool Burst (McNeil Consumer)

  • Description
  • Clinical Pharmacology
  • Indications and Usage
  • Dosage and Administration
  • Warnings
  • Overdosage
  • Description (2)
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    Each TYLENOL® Cold Severe Congestion Non-Drowsy Caplet with Cool Burst™ contains acetaminophen 325 mg, dextromethorphan HBr 15 mg, guaifenesin 200 mg and pseudoephedrine HCl 30 mg.


    TYLENOL® Cold Severe Congestion Non-Drowsy Caplets with Cool Burst™ contain a clinically proven analgesic-antipyretic, decongestant, expectorant and 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 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. Guaifenesin is an expectorant which helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. Dextromethorphan is a cough suppressant which provides temporary relief of coughs due to minor throat irritations that may occur with the common cold.


    temporarily relieves these cold symptoms:

    • cough · sore throat · minor aches and pains
    • headache · nasal congestion
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever


    • 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, dissolve.
    ·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.


    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

    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

    • 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 (1-800-222-1222) 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 at 20-25°C (68-77°F)

    See side panel for lot number and expiration date.


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

    Inactive Ingredients:    carnauba wax, cellulose, corn starch, croscamellose sodium, FD&C Blue #1 flavor, hypromellose, mannitol, povidone, silicon dioxide, stearic acid, sucralose, titanium dioxide


    Caplets:    White-colored, imprinted with "TYLENOL COLD SC" in blue ink--blister packs of 24 & 48 ct.

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    This page was last modified 30-JUN-07
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