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ACEPHEN (G&W Laboratories, Inc.)

Available Formats

Dosage Form Package Information Links
SUPPOSITORY 12 SUPPOSITORY in 1 BOX (0713-0118-12) Label Information
SUPPOSITORY 50 SUPPOSITORY in 1 BOX (0713-0118-50) Label Information
SUPPOSITORY 100 SUPPOSITORY in 1 BOX (0713-0118-01) Label Information

Complete ACEPHEN Information

  • ACTIVE INGREDIENT (in each rectal suppository)

    Acetaminophen 120 mg


  • PURPOSE

    Pain reliever/fever reducer


  • USES

    temporarily
    reduces fever
    relieves minor aches, pains, and headache


  • 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
    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.

    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.


  • 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.


  • 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
     


  • Other Information

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


  • Inactive ingredients

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


  • Questions?

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


  • PRINCIPAL DISPLAY PANEL

    NDC 0713-0118-50
    G&W Pediatric ACEPHENTM Acetaminophen Suppositories USP 120 mg
    ASPIRIN FREE
    Pain Reliever Fever Reducer
    50 Rectal Suppositories



    08/2013

    New Label

  • INGREDIENTS AND APPEARANCE
    ACEPHEN  
    acetaminophen suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) 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:0713-0118-12 12 in 1 BOX
    2 NDC:0713-0118-01 100 in 1 BOX
    3 NDC:0713-0118-50 50 in 1 BOX
    4 NDC:0713-0118-12 12 in 1 BOX
    5 NDC:0713-0118-01 100 in 1 BOX
    6 NDC:0713-0118-50 50 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018060 01/01/1982
    Labeler - G&W Laboratories, Inc. (001271188)
    Registrant - G&W Laboratories, Inc. (001271188)
    Establishment
    Name Address ID/FEI Business Operations
    G&W Laboratories, Inc. 001271188 MANUFACTURE(0713-0118)