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  5. Label Information: Regular Strength Pain Reliever

FDA Label for Regular Strength Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK DOCTOR BEFORE USE IF YOU HAVE
    8. ASK YOUR DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. STOP USE AND ASK A DOCTOR IF:
    10. IF PREGNANT OR BREAST-FEEDING,
    11. OVERDOSE WARNING:
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANELREGULAR STRENGTH PAIN RELIEVERACETAMINOPHEN 325MG- PAIN RELIEVER/ FEVER REDUCER30 TABLETS

Regular Strength Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Healthlife Of Usa. 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.

Drug Facts




Active Ingredient (In Each Tablet)



Acetaminophen 325mg


Purpose



Pain reliever/ Fever reducer


Uses



Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of 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 9 tablets (2925 mg) in 24 hours. Severe liver damage may occur if you take:

  • more than 3000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

    • Allergy alert:

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash 

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


Do Not Use



  • with any other drug containing acetaminophen (prescription or not prescription). 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 Doctor Before Use If You Have



liver disease


Ask Your 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.


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 tablets every 4 to 6 hours while symptoms last
  • do not take  more than 9 tablets in 24 hours period
  • do not use for more  than 10 days unless directed by doctor

    • Children 6 to 12 years: take 1 tablet every 4 to 6 hours while symptoms last

    • do not use more than 5 tablets in 24 hours period
    • children under 6 years ask doctor.

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

Inactive Ingredients



Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic acid, Talc, Titanium Dioxide.


Questions Or Comments?



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