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ACETAMINOPHEN 500 MG (acetaminophen 500 mg) Dailymed

  1. Human OTC
  2. Non-opioid Analgesics
  3. Reliable 1 Laboratories LLC

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

ACETAMINOPHEN 500 MG tablet - (acetaminophen 500 mg) image
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acetaminophen 500 mg oral tablet - ap 013 round white

acetaminophen 500 mg - ap 013 round white

  1. FDA Adverse Reactions

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Drug Facts

Active Ingredient (in Each Tablet)


Acetaminophen USP, 500 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 and menstrual cramps
  • temporarily reduces fever

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4,000 mg of acetaminophen 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

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 you have liver disease

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if you are 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
  • 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 & children 12 years and over:
  • take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last
  • do not take more than 8 tablets in 24 hours

children under 12 years: do not use

Other Information

  • store at 15º to 30ºC (59º to 86ºF)

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

Package Label.principal Display Panel


NDC 69618-011-01

Extra Strength

Acetaminophen USP 500 mg

PAIN RELIEVER

FEVER REDUCER

100 TABLETS

*Compare to Active Ingredient in Extra Strength Tylenol®



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