Label: ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository

  • NDC Code(s): 45802-732-30, 45802-732-33
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 10, 2021

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

  • 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

    Compare to FeverAll® active ingredient

    For Children

    Acetaminophen Suppositories USP, 120 mg

    Pain Reliever/Fever Reducer

    Ages 3-6 years

    See New Warning

    12 RECTAL SUPPOSITORIES, 120 mg EACH

    Acetaminophen Suppositories Image 1
    Acetaminophen Suppositories Image 2
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  FOR CHILDREN
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:45802-732-33100 in 1 CARTON12/14/2010
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:45802-732-3012 in 1 CARTON03/09/2011
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07060712/14/2010
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)