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  5. Label Information: Acetaminophen Extra Strength

FDA Label for Acetaminophen Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDEINTS
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    9. OTC - KEEP OUT OF REACH OF CHILDREN

Acetaminophen Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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


Uses



For the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

    • Temporarily reduces fever.


Warnings



Liver warning:

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

  • more than 8 caplets 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.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

      • 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 recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). 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.

Adults and children 12 years and over:

  • Take 2 caplets every 4 to 6 hours while symptoms last
  • Do not take more than 8 caplets in 24 hours
  • Do not take for more than 10 days unless directed by a doctor

    • Children under 12 years:

    • Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other Information



  • Store at room temperature 15°-30°C (59°-86°F)
  • Use by expiration date on package

Inactive Ingredeints



Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions? To report a Serious Adverse Event contact 1-877-835-5472.

*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol®.

Distributed by:

Amneal Pharmaceuticals

104 Hippocrates Way,

Glasgow, KY 42141

Rev. 11/2009



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146


Package Label.Principal Display Panel



AcetaminophenCapletsExtra Strength500 mgNDC 54868-3832-1

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


* Please review the disclaimer below.