Label: CETAFEN EXTRA- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL

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 11, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient (in each caplet): Acetaminophen 500mg

  • PURPOSE

    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

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

    • more than 8 caplets 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
  • 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

    • new symptms occur
    • redness or swelling is present
    • fever worsens or lasts more than 3 days
    • pain worsens or lasts 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 a Poison Control Center right away. 1-800-222-1222.

  • DOSAGE & ADMINISTRATION

    Directions: do not take more than directed

    • Adults and children 12 years of age and over:
    • take 2 caplets every 4 to 6 hours while symptoms persist
    • do not take more than 8 caplets 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    CetafenExtra.jpg

  • INGREDIENTS AND APPEARANCE
    CETAFEN EXTRA 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL METHYLCELLULOSE E5 [II] (UNII: R75537T0T4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code CFNX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0108-320 in 1 BOX, UNIT-DOSE
    12 in 1 PACKET
    2NDC:50332-0108-450 in 1 BOX, UNIT-DOSE
    22 in 1 PACKET
    3NDC:50332-0108-7125 in 1 BOX, UNIT-DOSE
    32 in 1 PACKET
    4NDC:50332-0108-8250 in 1 BOX, UNIT-DOSE
    42 in 1 PACKET
    5NDC:50332-0108-1400 in 1 BOX, UNIT-DOSE
    52 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/05/1990
    Labeler - HART Health (069560969)
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