Label: ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository

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

Drug Label Information

Updated February 15, 2021

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  • Active ingredient (in each rectal suppository)

    Acetaminophen 120 mg

  • Purposes

    Pain reliever/fever reducer

  • Uses

    temporarily

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

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

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.

  • 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 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
  • Other information

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

    hydrogenated vegetable oil

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    pdp

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  FOR CHILDREN
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4172(NDC:45802-732)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN120 mg
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4172-66 in 1 BLISTER PACK; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07060712/14/2010
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300repack(68071-4172)
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