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Generic: acetaminophen


IMPRINT: 44 531     SHAPE: round
    COLOR: red

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acetaminophen 500 mg oral tablet - 44 531 round red

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Active Ingredient (in Each Tablet)


Acetaminophen 500 mg 

Purpose


Pain reliever/fever reducer 

Uses

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

Warnings


Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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

  • 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 the 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 and over
    • take 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets in 24 hours unless directed by a doctor
    • do not take 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 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage 

Other Information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive Ingredients


corn starch, dextrose monohydrate, FD&C red #40, FD&C yellow #6, maltodextrin, povidone, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, sucralose, titanium dioxide 

Questions Or Comments?


 1-800-426-9391

Principal Display Panel


NDC 37205-593-78

Compare to Extra Strength Tylenol® EZ Tabs active ingredient*

LEADER®

EXTRA STRENGTH Pain Reliever Acetaminophen  Pain Reliever/Fever Reducer • Contains No Aspirin

Easy to Swallow Sweet Coated

Easy Tabs

100 TABLETS - 500 mg EACH

Actual Size

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® EZ Tabs.50844    REV0913B53112

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017CIN 4527750   www.myleader.com    1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Leader44-531A

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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