Label: FEVERALL INFANTS- acetaminophen suppository

  • 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

Drug Label Information

Updated 08/13

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

  • ACTIVE INGREDIENT

    Acetaminophen, USP 80 mg

    Close
  • PURPOSES

    Pain reliever/fever reducer

    Close
  • USES

    Temporarily

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

    Close
  • 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
    Close
  • ASK A DOCTOR BEFORE USE IF

    • the child has liver disease.
    • the child is taking the blood thinning drug warfarin.
    Close
  • 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.

    Close
  • 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.

    Close
  • 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
    Close
  • INACTIVE INGREDIENTS

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

    Close
  • QUESTIONS

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

    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    FEVERALL INFANTS 
    acetaminophen suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1200
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    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)
    Close