Label: FEVERALL INFANTS- acetaminophen suppository 

  • Label RSS
  • NDC Code(s): 0472-1200-06, 0472-1200-50
  • Packager: Actavis Mid Atlantic LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/13

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

  • ACTIVE INGREDIENT

    Acetaminophen, USP 80 mg

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  • PURPOSES

    Pain reliever/fever reducer

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  • USES

    Temporarily

    • reduces fever
    • relieves minor aches, pains, and headache
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  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
    • more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
    • 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

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  • 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
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  • ASK A DOCTOR BEFORE USE IF

    • the child has liver disease.
    • the child is taking the blood thinning drug warfarin.
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  • STOP USE AND ASK A DOCTOR IF

    • fever lasts more than 3 days (72 hours), or recurs.
    • pain lasts more than 3 days or gets worse.
    • new symptoms occur.
    • redness or swelling is present in the painful area.

    These may be signs of a serious condition.

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

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  • 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
     Age  Dose
     under 6 months  Do not use unless directed by a doctor
     6 to 11 months  Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours)
     12 to 36 months  Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

    Other information

    • store at 2º-27ºC (35º-80ºF)
    • do not use if imprinted suppository wrapper is opened or damaged
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  • INACTIVE INGREDIENTS

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

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  • QUESTIONS

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Infants’

    Ages 6-36 months

    80 mg

    NDC 0472-1200-06

    FeverAll®

    Acetaminophen Suppositories

    Pain reliever/fever reducer

    6 Rectal Suppositories

    80 mg each

    1
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  • INGREDIENTS AND APPEARANCE
    FEVERALL INFANTS 
    acetaminophen suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0472-1200
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERYL MONOSTEARATE  
    POLYSORBATE 80  
    HYDROGENATED PALM KERNEL OIL  
    PEG-100 STEARATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-1200-06 6 in 1 BOX
    2 NDC:0472-1200-50 50 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA018337 04/01/1980
    Labeler - Actavis Mid Atlantic LLC (809515898)
    Establishment
    Name Address ID/FEI Business Operations
    Actavis Mid Atlantic LLC 809515898 ANALYSIS(0472-1200), LABEL(0472-1200), MANUFACTURE(0472-1200), PACK(0472-1200)
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