Label: CETAFEN- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 29, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet): Acetaminophen 325mg

  • PURPOSE

    Pain Reliever/Fever Reducer

  • 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

  • WARNINGS

    Warnings:

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:  Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • rash
    • blisters

  • DO NOT USE

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

  • 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

  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • STOP USE

    Stop use and ask a doctor if:

    • an allergic reaction occurs, seek medical help right away
    • new symptoms 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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • 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

  • 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: ask a doctor

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CETAFEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code CFN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0103-450 in 1 BOX, UNIT-DOSE06/04/1986
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0103-7125 in 1 BOX, UNIT-DOSE06/04/1986
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0103-8250 in 1 BOX, UNIT-DOSE06/04/1986
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0103-1500 in 1 BOX, UNIT-DOSE06/04/1986
    42 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/04/1986
    Labeler - HART Health (069560969)