Label: ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER- acetaminophen suppository

  • NDC Code(s): 45802-730-00, 45802-730-30, 45802-730-32, 45802-730-33
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 9, 2021

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  • Active ingredient (in each rectal suppository)

    Acetaminophen 650 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

    •
    an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
    •
    taken with other drugs containing acetaminophen
    •
    an adult takes 3 or more alcoholic drinks every day while using this product

    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

    •
    in children under 12 years
    •
    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

    •
    you have liver disease
    •
    you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    •
    fever lasts more than 3 days (72 hours), or recurs.
    •
    pain gets worse or lasts more than 10 days.
    •
    new symptoms occur.
    •
    redness or swelling is present in the painful area. These may be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    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

    •
    do not use more than directed
    •
    remove wrapper
    •
    carefully insert suppository well up into the rectum
    •
    adults and children 12 years and older:
    •
    1 suppository every 4 to 6 hours while symptoms last
    •
    do not exceed 6 suppositories in any 24 hour period
    •
    children under 12 years: ask a doctor
  • 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 Adults

    Acetaminophen Suppositories USP, 650 mg

    Pain Reliever/Fever Reducer

    Ages 12 years and older

    See New Warning

    50 RECTAL SUPPOSITORIES, 650 mg EACH

    Acetaminophen Suppositories Image 1
    Acetaminophen Suppositories Image 2
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  PAIN RELIEVER FEVER REDUCER
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-730
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-730-3250 in 1 CARTON11/22/2010
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:45802-730-3012 in 1 CARTON10/28/2010
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:45802-730-33100 in 1 CARTON10/28/2010
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:45802-730-001 in 1 BLISTER PACK; Type 0: Not a Combination Product10/28/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07060810/28/2010
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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