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  5. Label Information: Feverall Childrens

FDA Label for Feverall Childrens

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH RECTAL SUPPOSITORY)
    3. PURPOSES
    4. USES
    5. LIVER WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 120 MG SUPPOSITORY BLISTER PACK CARTON

Feverall Childrens Product Label

The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a. Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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.

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


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

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

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.


Otc - Keep Out Of Reach Of Children



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


Principal Display Panel - 120 Mg Suppository Blister Pack Carton



NDC 51672-2115-2

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

* Please review the disclaimer below.