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Acetaminophen (acetaminophen 650 mg) Dailymed

  1. Human OTC
  2. Non-opioid Analgesics
  3. Aurohealth LLC

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

Acetaminophen tablet, extended release - (acetaminophen 650 mg) image
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IMPRINT: I 06     SHAPE: oval
    COLOR: white

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acetaminophen 650 mg - i 06 oval white

acetaminophen 650 mg - i 90 oval white

  1. FDA Adverse Reactions

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Drug Facts


Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

Purpose


Pain reliever/fever reducer

Uses

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

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 6 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • 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 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: 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:
  • take 2 tablets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor.

Under 18 years of age:
  • ask a doctor

Other Information

  • store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
  • do not use if carton is opened or foil inner seal is broken
  • Meets USP dissolution test 3

Inactive Ingredients


colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin Questions or comments?   call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009

Package Label-principal Display Panel - 650 Mg (225 Tablets Bottle)


AUROHEALTH TO OPEN: 1. PUSH DOWN         NDC 58602-730-28                    2. TURN CAP DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR    ARTHRITIS PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain 225 Extended-release tablets           

Package Label-principal Display Panel - 650 Mg (225 Tablets Container Carton)


AUROHEALTH NDC 58602-730-28 *Compare to the Active Ingredient in Tylenol® 8 HR Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR ARTHRITIS PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain 225 Extended-release tablets

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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