Label: FEVER REDUCING CHILDRENS- acetaminophen suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

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 09/11

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

  • Active ingredient (in each rectal suppository)

    Acetaminophen 120 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily

    • reduces fever
    • relieves minor aches, pains, and headache
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  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    For rectal use only

    Do not use

    • if you are allergic to acetaminophen
    • 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

    • your child has liver disease
    • your child is taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • fever lasts more than 3 days (72 hours), or recurs.
    • pain lasts more than 5 days or gets worse.
    • new symptoms occur.
    • redness or swelling is present in the painful area.

    These may be signs of a serious condition.

    Keep out of reach of children.

    If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

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  • Directions

    • this product does not contain directions or warnings for adult use
    • do not use more than directed
    • remove wrapper
    • carefully insert suppository well up into the rectum
    Dosing Chart
    Age Dose
    under 3 years Do not use unless directed by a doctor
    3 to 6 years Use a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
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  • Other information

    • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
    • store at 20°-25°C (68°-77°F) or in a cool place
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  • Inactive ingredients

    hydrogenated vegetable oil

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient in FeverAll®

    See New Warnings Information

    Children's

    FEVER REDUCING SUPPOSITORIES

    ACETAMINOPHEN SUPPOSITORIES 120 mg

    Pain reliever / Fever reducer

    Read and Keep Carton for New Liver Warning

    120 mg EACH

    Fever Reducing Suppositories Carton Image 1

    Fever Reducing Suppositories Carton Image 1

    Fever Reducing Suppositories Carton Image 2

    Fever Reducing Suppositories Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    FEVER REDUCING  CHILDRENS
    acetaminophen suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-579
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-579-53 2 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA070607 01/21/2010
    Labeler - CVS Pharmacy (062312574)
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