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  5. Label Information: Pain Reliever

FDA Label for Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES:
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Health Pharma Usa 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 500 mg


Purpose



Pain reliever/Fever reducer


Uses:



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

Warnings



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3000 mg) in 24 hours. 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 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.

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 recommended 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.


Directions



  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over:
  • take 2 caplets every 6 hours while symptoms last
  • do not take mote than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
  • children under 12 years of age: do not use

Other Information



  • store at 15° to 30°C (59° to 86°F)
  • read all product information before using

Inactive Ingredients



Pregelatinized Starch, Povidone, Stearic Acid powder, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose, Polyethylene Glycol, Titanium Dioxide, Talc


Questions Or Comments?



Call +1-844-832-1138 Mon - Fri 9 AM - 5 PM EST


Package Label.Principal Display Panel



label - label

label - label


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