Label: CETAFEN- acetaminophen tablet 

  • NDC Code(s): 50332-0103-1, 50332-0103-4, 50332-0103-7, 50332-0103-8
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet): Acetaminophen 325mg

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  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor arthritis pain
    • the common cold
    • toothache
    • menstrual cramps

    Temporarily reduces fever

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  • WARNINGS

    Warnings:

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

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

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  • DO NOT USE

    Do not use with any other drug containing acetaminophen (prescription or non-prescription)

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if:

    • you are taking the blood thinning drug warfarin
    • you do not know if other drugs you are taking contain acetaminophen

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  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

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  • STOP USE

    Stop use and ask a doctor if:

    • new symptom occur
    • redness or swelling is present
    • fever worsens or lasts for more than 3 days
    • pain worsens or lasts for more than 10 days

    These could be signs of a serious condition

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • OVERDOSAGE

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact Poison Control Center right away. 1-800-222-1222

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  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed

    Adults and children 12 year of age and over:

    • take 2 tables every 4 to 6 hours while symptoms persist
    • do not take more than 8 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: do not use; this will provide more than the recommended dose (overdose) for children under 12 years of age and may cause liver damage

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

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  • INGREDIENTS AND APPEARANCE
    CETAFEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0103
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    STEARIC ACID  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code CFN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0103-4 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0103-7 125 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0103-8 250 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    4 NDC:50332-0103-1 500 in 1 BOX, UNIT-DOSE
    4 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/04/1986
    Labeler - HART Health (069560969)
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