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ACETAMINOPHEN (acetaminophen 325 mg) Dailymed

  1. Human OTC
  2. Non-opioid Analgesics
  3. Akron Pharma Inc.

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

ACETAMINOPHEN tablet - (acetaminophen 325 mg) image
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IMPRINT: AP 325     SHAPE: round
    COLOR: white

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acetaminophen 325 mg - ap 325 round white

  1. FDA Adverse Reactions

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Active Ingredient (in Each Tablet)


Acetaminophen 325 mg

Purpose


Pain Reliever/Fever Reducer

Uses


To reduce fever and 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. Severe liver damage may occur if 
  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours 
  • taken with other drugs containing acetaminophen 
  • adult has 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

  • has liver disease
  • is a child with pain of arthritis

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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 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 & children12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 children 6-11 years
  •  take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
 child under 6 years  ask a doctor

Other Information

  • store at temperature 15° to 30°C (59° to 86°F)

Inactive Ingredients:


colloidal silicon dioxide, microcrystalline cellulose, polacrilin potassium, propylparaben, povidone, stearic acid.

Questions Or Comments?


Call toll-free 1-877-225-6999

Manufactured for Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

Mfg. Lic. No: TN/DRUGS/558/1997

* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

Package Label.principal Display Panel


325mg - Unit Dose



 325 mg -100 Tablets



325mg -1000 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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