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  5. Label Information: Acetaminophen Pain Reliever Fever Reducer

FDA Label for Acetaminophen Pain Reliever Fever Reducer

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. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Acetaminophen Pain Reliever Fever Reducer Product Label

The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. 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 650 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

  • •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 every day 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 12 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. (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



  • •do not use more than directed
  • •remove wrapper
  • •carefully insert suppository well up into the rectum
  • •adults and children 12 years and older:
  • •1 suppository every 4 to 6 hours while symptoms last
  • •do not exceed 6 suppositories in any 24 hour period
  • •children under 12 years: ask a doctor

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


Principal Display Panel



Compare to FeverAll® active ingredient

For Adults

Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

Ages 12 years and older

See New Warning

50 RECTAL SUPPOSITORIES, 650 mg EACH

Acetaminophen Suppositories Image 1 - image 01

Acetaminophen Suppositories Image 1 - image 01


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