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Generic: acetaminophen


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acetaminophen 500 mg - gpi a5 round white

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

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Active Ingredient


Drug Facts

Acetaminophen 500mg (in each tablet)

ASPIRIN FREE EXTRA STRENGTH PAIN RELIEVER

Purposes


Pain Reliever/Fever Reducer

Use(s)


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


See New Warnings Information and Directions

This unit dose package is not child resistant and is intended for institutional use only. Keep out of reach of children.

Tamper Evident: Do not use if sealed buler units are broken or damaged.

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.

Symptoms may include: - skin reddening – bulers – rash

If skin reactions 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.

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.

Pregnancy/Breastfeeding


If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children


Keep out of reach of children.

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 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 room temperature.

Inactive Ingredients


Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions


Questions or comments? To Report Adverse Drug Event call (800) 616-2471.

Distributed by:

Major® Pharmaceuticals

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

Distributed by Cardinal Health

Dublin, OH 43017

L4387353-10518

L4387353-20518

Principal Display Panel


Mapap Tablets

Extra Strength Acetaminophen

500 mg

10 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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