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TYLENOL (acetaminophen 500 mg) Dailymed

  1. Human OTC
  2. Prostaglandin Receptor Antagonists
  3. Johnson & Johnson Consumer Inc.

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

TYLENOL tablet, coated - (acetaminophen 500 mg) image
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IMPRINT: TY 500     SHAPE: oval

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acetaminophen 500 mg - ty 500 capsule red

acetaminophen 500 mg - ty 500 oval red

tylenol extra strength (acetaminophen) tablet, coated - ty 500 capsule red

tylenol extra strength (acetaminophen) tablet, coated - ty 500 oval red

  1. FDA Adverse Reactions

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Drug Facts

Active Ingredient (in Each Gelcap)


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 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

Overdose warning


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

adults and children 12 years and over
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor

Other Information

  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive Ingredients


benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide

Questions Or Comments?


call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel


NDC 50580-488-24

Extra Strength TYLENOL ® FOR ADULTS

Acetaminophen Pain Reliever Fever Reducer

RAPID RELEASE GELS

Actual Size

24 Gelcaps* 500 mg each

*Gelatin-Coated 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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