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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

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 THE USER HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
    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

Acetaminophen 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 325 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 
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adults has 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 The User Has



liver disease


Ask A Doctor Or Pharmacist Before Use If The User Is



taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If:



  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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:  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



  • adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take mote than 10 tablets in 24 hours, unless directed by doctor
  • do not use for more than 10 days unless directed by a doctor
  • children 6 years to under 12 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by doctor

Other Information



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

Inactive Ingredients



Pregelatinized Starch, Polyvinyl Pyrrolidone, Microcrystalline Cellulose, Stearic acid powder,  Magnesium Stearate, Hypromellose-5 & 15, Polyethylene Glycol-400, Talc, Titanium Dioxide.


Questions Or Comments?



Call toll free 1-844-832-1138 Monday through Friday 9 AM - 5 PM EST


Package Label.Principal Display Panel



1 - label

1 - label


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