Label: FEVERALL CHILDRENS- acetaminophen suppository

  • NDC Code(s): 51672-2115-0, 51672-2115-2, 51672-2115-4
  • Packager: Taro Pharmaceuticals U.S.A. Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 26, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each rectal suppository)

    Acetaminophen, USP 120 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 your child takes

    • more than 5 doses 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.

    For rectal use only.

    Do not use

    • 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

    • the child has liver disease.
    • the 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.
    • pain lasts more than 5 days or gets worse.
    • new symptoms occur.
    • redness or swelling is present in the painful area.

    These may be signs of a serious condition.

    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 adults and for children even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or warnings for adult use
    • do not use more than directed
    • remove wrapper
    • carefully insert suppository well up into the rectum
    Dosing Chart
    AgeDose
    under 3 yearsDo not use unless directed by a doctor
    3 to 6 yearsUse 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
  • Other information

    • store at 2°-27°C (35°-80°F)
    • do not use if imprinted suppository wrapper is opened or damaged
  • Inactive ingredients

    glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

  • Questions?

    call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Dist. by: Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton

    NDC 51672-2115-2

    RECTAL
    SUPPOSITORY*

    *actual size

    Doctor Recommended

    Pain Reliever/Fever Reducer

    ✓
    No Parabens or Any Other Preservatives
    ✓
    No Artificial Colors

    CHILDREN'S

    ages 3-6 years

    FeverAll®

    ACETAMINOPHEN SUPPOSITORIES

    Pain Reliever/Fever Reducer

    6
    Rectal
    Suppositories

    120
    mg
    each

    PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    FEVERALL   CHILDRENS
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2115
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen120 mg
    Inactive Ingredients
    Ingredient NameStrength
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hydrogenated palm kernel oil (UNII: FM8D1RE2VP)  
    PEG-100 stearate (UNII: YD01N1999R)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2115-26 in 1 CARTON12/12/2013
    1NDC:51672-2115-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51672-2115-450 in 1 CARTON12/12/2013
    2NDC:51672-2115-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01833712/12/2013
    Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    G&W NC Laboratories, Inc.079419931MANUFACTURE(51672-2115)
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