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  5. Label Information: Acetaminophen For Children

FDA Label for Acetaminophen For Children

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH RECTAL SUPPOSITORY)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Acetaminophen For Children Product Label

The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,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.

Active Ingredient (In Each Rectal Suppository)



Acetaminophen 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



  • your child has liver disease
  • your 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. (1-800-222-1222) 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

    Age

    Dose

    under 3 years

    Do not use unless directed by a doctor

    3 to 6 years

    Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)


Other Information



  • store at 20-25 °C (68-77 °F) or in a cool place
  • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.

Inactive Ingredient



hydrogenated vegetable oil


Questions Or Comments?



1-800-719-9260


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