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TYLENOL (acetaminophen 500 mg) Dailymed


Generic: acetaminophen


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Drug Facts

Active Ingredient (in Each Tablet)


Acetaminophen 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 8 tablets 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

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

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

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 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 tablets every 4 to 6 hours while symptoms last
  • if needed, tablets may be crushed and should be taken immediately. Take the entire dose for best result. Crushing the tablets will result in a bitter taste.
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken or missing
  • see end panel for lot number and expiration date

Inactive Ingredients


corn starch, magnesium stearate, powdered cellulose, pregelatinized starch, sodium starch glycolate

Questions Or Comments?


call 1-877-895-3665

Principal Display Panel


NDC 50580-499-68

See New Warnings Information

TYLENOL®

Pain RelieverFever ReducerAcetaminophen

EXTRASTRENGTH

60 TABLETS500 mg each

TabletsCrushable•Dye Free

Containsno aspirin

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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