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  5. Label Information: Extra Strenghth Acetaminophen

FDA Label for Extra Strenghth Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. IF PREGNANT OR BREAST-FEEDING
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strenghth Acetaminophen Product Label

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

Acetaminophen 500mg


Purpose



Pain reliever/fever reducer


Uses



  • temporary relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps and
  • temporarily reduces fever

Warnings



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

  • more than 4,000 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 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 (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
      • 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 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.



Overdose warning: Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.


Directions



  •  do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older:
  • Take 2 caplets every 6 hours while symptoms last.
  • Do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • Do not use more than 10 days unless directed by a doctor.
  • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information



  • store at controlled room temperature 20-25°C (68-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

* Please review the disclaimer below.