Label: ACETAMINOPHEN - acetaminophen suppository

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

Drug Label Information

Updated June 6, 2012

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

    For rectal use only
    Liver Warning:
    This product contains acetaminophen. Severe liver damage may occur if your child inserts:
    • more than 5 suppositories in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Do not use
    • if your child is 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

    Ask a doctor or pharmacist before use if 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
    • you need to use this product for pain for more than 5 days continuously
    Severe or recurrent pain, or high or continued fever may indicate a serious illness.

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for children even if you do not notice any signs or symptoms.

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  • DOSAGE & ADMINISTRATION

    Directions
    This product does not contain directions or complete warnings for adult use.
    do not use more than directed
    • remove foil wrapper
    • insert suppository well up into rectum
    • children 3-6 years:
       • 1 suppository every 4 to 6 hours while symptoms persist
       • do not exceed 5 suppositories in any 24-hour period
    • children under 3 years: ask a doctor

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  • Other Information

    • for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
    • store at 8˚-25˚C (46˚-77˚F)

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  • INACTIVE INGREDIENT

    butylated hydroxyanisole, butylated hydroxytoluene, glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, polysorbate 80

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  • QUESTIONS

    call 1-800-922-1038
    Monday-Friday 9am-4pm EST

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    SEE NEW WARNINGS INFORMATION
    READ AND KEEP CARTON FOR NEW LIVER WARNING
    NDC 54868-5624-0
    12 rectal suppositories
    Acetaminophen Suppositories USP 120 mg
    ASPIRIN FREE
    Pain Reliever • Fever Reducer
    50 Rectal Suppositories

    Packaging Carton
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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5624(NDC:0713-0118)
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hydrogenated Coconut Oil (UNII: JY81OXM1OM)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-5624-0 12 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018060 06/29/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
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