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ACETAMINOPHEN 325 MG (acetaminophen 325 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Preferred Pharmaceuticals Inc.

Generic: acetaminophen

ACETAMINOPHEN 325 MG tablet - (acetaminophen 325 mg) image

IMPRINT: AP 012     SHAPE: round
    COLOR: white

  1. FDA Adverse Reactions

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Drug Facts

Active Ingredient (in Each Tablet)


Acetaminophen USP, 325 mg

Purpose


Pain reliever/fever reducer

Uses

  • •temporarily relieves minor aches and pains due to:
  • •headache
  • •muscular aches
  • •backache
  • •minor pain of arthritis
  • •the common cold
  • •toothache
  • •premenstrual or 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 in 24 hours, which is the maximum daily amount
  • •child takes more than 5 tablets in 24 hours, which is the maximum daily amount
  • •taken with other drugs containing acetaminophen
  • •adult has 3 or more alcoholic drinks while using this product

Other Safety Information


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.

Otc - Do Not Use Section


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.

Otc - Ask Doctor Section


Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/pharmacist Section


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

Otc - Stop Use Section


Stop use and ask a doctor if
  • •pain gets worse or lasts more than 10 days in adults
  • •pain gets worse or lasts more than 5 days in 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.

Otc - Keep Out Of Reach Of Children Section


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. 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 4-6 hours while symptoms last, not more than 12 tablets in 24 hours

children 6 to 11 years
take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours

children under 6 years
do not use

Other Information

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

Inactive Ingredients


povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments?


call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday


TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Repackaged By: Preferred Pharmaceuticals Inc.

Package Label.principal Display Panel


NDC 68788-7245

Regular Strength

Acetaminophen USP 325 mg

PAIN RELIEVER

FEVER REDUCER

*Compare to Active Ingredient in Regular Strength TYLENOL®

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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