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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. OVERDOSAGE
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIETNS:
    10. DISTRIBUTOR INFORMATION:

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Keltman 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 tablet)

Acetaminophen 500 mg


Purposes



Pain Reliever/Fever Reducer


Keep Out Of Reach Of Children



Keep out of reach of children


Uses



  • temporarily relieves minor aches and pains
  • temporarily relieves reduces fever

Warnings



Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • Do not use

    • 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.

      Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

      Stop use and ask a doctor if

      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • new symptoms occur
      • redness or swelling is present

        • These could be signs of a serious condition.

        If pregnant or breast-feeding, ask a health professional before use.

        Keep out of reach of children.


Overdosage



Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



Do not take more than directed

AgeDose
Adults and Children 12
years and over		Take 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 yearsDo not use.

Other Information



TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

  • store at 20°-25°C (68°-77°F)
  • for institutional use only

Inactive Ingredietns:



povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben


Distributor Information:



*This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1650 63rd St., Brooklyn, New York 11204

This Product was Repackaged By Sandhills Packaging For:

Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States


* Please review the disclaimer below.