Label: ACEPHEN- acetaminophen suppository

  • NDC Code(s): 0713-0118-01, 0713-0118-12, 0713-0118-50
  • Packager: Cosette Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 26, 2019

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

  • 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 8˚-25˚C (46˚-77˚F)

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0118
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN120 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0713-0118-1212 in 1 BOX; Type 0: Not a Combination Product01/01/1982
    2NDC:0713-0118-01100 in 1 BOX; Type 0: Not a Combination Product01/01/1982
    3NDC:0713-0118-5050 in 1 BOX; Type 0: Not a Combination Product01/01/1982
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01806001/01/1982
    Labeler - Cosette Pharmaceuticals, Inc. (116918230)
    Registrant - Cosette Pharmaceuticals, Inc. (116918230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosette Pharmaceuticals, Inc.116918230analysis(0713-0118) , manufacture(0713-0118) , label(0713-0118) , pack(0713-0118)