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Extra Strength Pain Reliever (acetaminophen 500 mg) Dailymed

  1. Human OTC
  2. Non-opioid Analgesics
  3. FRED'S, INC.

Generic: acetaminophen is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain

Extra Strength Pain Reliever tablet - (acetaminophen 500 mg) image
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IMPRINT: 44 531     SHAPE: round
    COLOR: red

All Imprints

acetaminophen 500 mg oral tablet - 44 531 round red

  1. FDA Adverse Reactions

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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
    • toothache
    • muscular aches
    • 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. 

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 ore 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 (1-8000-222-1222) 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 4 to 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use this 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


D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient 

Principal Display Panel


FRED'S®

Extra Strength Non-Aspirin Pain Reliever Pain Reliever/Fever Reducer

Acetaminophen EZ Tabs100 Tablets - 500 mg each Tested Against The Active Ingredient In: Extra Strength TYLENOL®  EZ TABS†

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

50844        REV0213D53112

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Fred's 44-531

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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