Label: ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER- acetaminophen suppository

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

Drug Label Information

Updated April 13, 2011

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  • Active ingredient (in each rectal suppository)

    Acetaminophen 650 mg

  • Purpose

    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

    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

    • 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
  • Inactive ingredients

    hydrogenated vegetable oil

  • Questions or comments?

    1-800-719-9260

  • PRINCIPAL DISPLAY PANEL

    Acetaminophen Suppositories USP, 650 mg

    NDC 54868-4991-0

    image of package label

    Pain Reliever/Fever Reducer

    See New Warnings Information

    Read and Keep Carton for New Liver Warning

    650 mg Each

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  PAIN RELIEVER/FEVER REDUCER
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4991(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
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-4991-02 in 1 CARTON
    16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07060802/03/2004
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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