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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. INACTIVE INGREDIENTS:
    4. USES:
    5. WARNINGS:
    6. DO NOT USE:
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    8. ASK A DOCTOR BEFORE USE IF
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING:
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS:
    13. OTHER INFORMATION:
    14. PACKAGE LABELING:

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Global Pharm Distribution Llc. 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 Caplet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Inactive Ingredients:



Corn Starch, Magnesium Stearate, Sodium Starch Glycolate, PVP.


Uses:



  • Temporarily relieves minor aches and pains due to
  • headache
  • the common cold
  • muscular aches
  • backache
  • toothache
  • premenstrual and menstrual cramps
  • minor pain of arthritis
  • Temporarily reduces fever.

Warnings:



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

  • more than 4000 mg of acetaminophen in 24 hours.
  • with other drugs containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product.

    • Allergy alert: Acetaminophen may cause a severe skin reactions. Symptoms may include

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.


Do Not Use:



  • with any other drug containing acetaminophen - if you are not sure whether a drug contains acetaminophen - ask a doctor or pharmacist
  • for more than 10 days for pains unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have:



  • liver disease.

Ask A Doctor 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
  • ever gets worse or lasts more than 3 days
  • 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.



Overdose warning. 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 noti ce any signs or symptoms.


Directions:



do not take more than directed (see overdose warning).

Adults and children 12 years and over:

  • take 2 caplets every 6 hours while symptoms last, do not take more than 6 caplets in 24 hours.
  • do not take more than 10 days unless directed by a doctor.

    • Children under 12 years: ask a doctor.


Other Information:



Store at 20 - 25°C (68 - 77°F).


Package Labeling:



Label - Label

Label - Label


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