Label: FEVERALL JR. STRENGTH- acetaminophen suppository

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

Drug Label Information

Updated October 1, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each rectal suppository)

    Acetaminophen, USP 325 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

    • a child 6 to 12 years takes more than 5 doses in 24 hours
    • 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 everyday while using this product

    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

    • in children under 6 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. 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

    • remove wrapper
    • do not use more than directed
    • carefully insert suppository well up into the rectum
    Dosing Chart
    AgeDose
    under 6 yearsdo not use
    6 to 12 yearsUse 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours)
    adults and children 12 years and olderUse 2 suppositories every 4 to 6 hours. (maximum of 6 doses)
  • 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

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

  • HOW SUPPLIED

    Product: 63629-8240

    NDC: 63629-8240-1 12 SUPPOSITORY in a BOTTLE

  • Acetaminophen Supp. 325mg Blister Pack

    Label Image
  • INGREDIENTS AND APPEARANCE
    FEVERALL   JR. STRENGTH
    acetaminophen suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-8240(NDC:51672-2116)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 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:63629-8240-112 in 1 BOTTLE; Type 0: Not a Combination Product09/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01833712/12/2013
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-8240) , RELABEL(63629-8240)
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