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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. WARNINGS
    4. LIVER WARNING:
    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. OVERDOSE WARNING:
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    16. USES

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Tds Pharm Co., Ltd. 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 Ingredients (In Each Tablet)



                       

Acetaminophen 500mg



Purpose



Pain Reliever/fever reducer

Warnings





Liver Warning:



this product contains acetaminophen.  Severe liver damage may occur if you take
  • more than 8 tablets in 24 hours, which is the maxium 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



  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
    • These could be sign of a serious condition

If Pregnant Or Breast-Feeding



ask a health professional before use.


Keep Out Of Reach Of Children.



Enter section text here


Overdose Warning:



Taking more than the recommended dose(overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center 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 and over
    • take 2 tablets every 4 to 6 house as needed
    • do not take more than 8 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor


    children under 12 years
    		do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
                          

Other Information



  • do not use if imprinted safety seal under cap is broken or missing.
  • Store at 15° - 30°C (59° - 86°F)
  • see end panel for lot number and expiration date

Inactive Ingredients



benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride


Package Label.Principal Display Panel



non-aspirin 50 tablet

image of carton label - nonasp50.carton

image of carton label - nonasp50.carton


Uses



temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • mentrual cramps
  • temporarily reduces fever

* Please review the disclaimer below.