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Generic: acetaminophen


IMPRINT: GPI A5     SHAPE: oval
    COLOR: white

All Imprints

pain and fever - acetaminophen 500 mg oral tablet - gpi a5 oval white

acetaminophen 500 mg - gpi a5 capsule white

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Active Ingredient (in Each Caplet)


Acetaminophen 500 mg

Purposes


Pain reliever/fever reducer

Uses

  • 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. The maximum daily dose of this product is 6 caplets (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 non prescription). 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION


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 the 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 and children 12 years and over:
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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: ask a doctor

Other Information

  • Do not use if imprinted safety seal under cap is broken or missing.
  • Store at room temperature

Inactive Ingredients


Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?


If you have any questions or comments, or to report an adverse event, please contact 1 800-medline.

Principal Display Panel


ONDRA PHARMACEUTICALS See New Warnings Information and Directions Extra Strength Acetaminophen 500 mg PAIN RELIEVER FEVER REDUCER CONTAINS NO ASPIRIN Compare to the Active ingredient in Extra Strength Tylenol® This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® 1000 CAPLETS 500 mg each

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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