Label: DRISTAN COLD MULTISYMPTOM- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet

  • NDC Code(s): 0573-1238-21
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/10

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Acetaminophen, USP 325 mg

    Chlorpheniramine maleate, USP 2 mg

    Phenylephrine HCl, USP 5 mg

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  • PURPOSES

    Pain reliever/Fever reducer

    Antihistamine

    Nasal decongestant

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  • USES

    • temporarily relieves these symptoms associated with a cold, or flu:
      • headache
      • nasal congestion
      • sore throat
      • fever
      • minor aches and pains
    • temporarily relieves minor aches, pains and headache as well as these symptoms of hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • nasal congestion
      • itching of the nose or throat
      • itchy, watery eyes
    • temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
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  • WARNINGS

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 12 tablets in any 24-hour period, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    • to sedate a child or to make a child sleepy
    • 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking any other oral nasal decongestant or stimulant
    • taking any other pain reliever/fever reducer
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • 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

    • you get nervous, dizzy, or sleepless
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

    Directions

    • do not use more than 12 tablets in any 24-hour period
    • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage
    • this adult product is not intended for use in children under 12 years of age
    age dose
    adults and children 12 years and over 2 tablets every 4 hours
    children under 12 years do not use
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  • OTHER INFORMATION

    • store at 20-25°C (68-77°F)
    • tamper-evident individual blisters
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  • INACTIVE INGREDIENTS

    calcium stearate, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

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  • QUESTIONS OR COMMENTS?

    Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026

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  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    See new warnings information

    Dristan Cold

    Acetaminophen >> Pain reliever/Fever reducer

    Chlorpheniramine maleate >> Antihistamine

    Phenylephrine HCl >> Nasal Decongestant

    Multi-symptom formula

    For relief of Nasal Congestion, Sinus Pressure, Headache, Aches and Pains, Fever, Runny Nose and Sneezing

    20 COATED TABLETS

    Tablets individually blister sealed. If seal is broken, Do Not Use.

    Wyeth Consumer Healthcare

    Madison, NJ 07940 USA

    Made in Canada ©2009 Wyeth

    For most recent product information, visit www.dristan.com

    Dristan Cold Packaging
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  • INGREDIENTS AND APPEARANCE
    DRISTAN COLD MULTISYMPTOM 
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-1238
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    acetaminophen (acetaminophen) acetaminophen 325 mg
    chlorpheniramine maleate (chlorpheniramine ) chlorpheniramine maleate 2 mg
    phenylephrine hydrochloride (phenylephrine ) phenylephrine hydrochloride 5 mg
    Product Characteristics
    Color YELLOW (Upper Yellow Layer) , WHITE (Bottom White Layer) Score no score
    Shape ROUND (Round film-coated tablet) Size 5mm
    Flavor Imprint Code d
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-1238-21 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/05/2005
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Canada 206472008 MANUFACTURE, ANALYSIS
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