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  5. Label Information: Extra Strength Pain Relief

FDA Label for Extra Strength Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. OVERDOSE WARNING
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Extra Strength Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical 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 Softgel)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer 


Uses



  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • 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 are allergic to acetaminophen or any of the inactive ingredients in this product

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.


Overdose Warning



In 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 (see Overdose warning)

    • adults and children 12 years and over

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

    children under 12 years

         ask a doctor


Other Information



  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients



FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink


Questions Or Comments?



Call toll free: 1-855-215-8180


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Extra Strength Pain Relief

Acetaminophen 500 mg 80 SOFTGELS

NDC 51013-182-26

*Compare to the active ingredient in TYLENOL® Extra Strength


* Please review the disclaimer below.