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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. STOP USE AND ASK A DOCTOR IF:
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS - DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS:
    12. QUESTIONS OR COMMENTS?

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma Inc.. 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



To reduce fever and for the temporary relief of minor aches and pains due to:

  • •headache
  • •muscular aches
  • •backache
  • •minor pain of arthritis
  • •the common cold
  • •toothache
  • •premenstrual and menstrual cramps.

    • Temporarily reduces fever.


Warnings



Liver warning:

This product contains acetaminophen. 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 
  • taken with other drugs containing acetaminophen 
  • adult 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If The User Has



  • has liver disease
  • is a child with pain of arthritis

Stop Use And Ask A Doctor If:



  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.


Keep Out Of Reach Of Children.



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.(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 & children 12 years and over
  •  take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 child under 12 years ask a doctor


Other Information



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

Inactive Ingredients:



colloidal silicon dioxide, microcrystalline cellulose, polacrilin potassium, propylparaben, povidone, stearic acid.


Questions Or Comments?



Call toll-free 1-877-225-6999

Manufactured for
Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

Mfg. Lic. No: TN/DRUGS/558/1997

* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.


* Please review the disclaimer below.