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Tempra (acetaminophen 500 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.

Generic: acetaminophen

Tempra tablet - (acetaminophen 500 mg) image

IMPRINT: 500 9239M     SHAPE: capsule
    COLOR: white

  1. FDA Adverse Reactions

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Drug Facts


Active Ingredient (in each tablet)

Acetaminophen 500 mg

Otc - Purpose Section


Purpose

Pain reliever / fever reducer

Indications & Usage Section


Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings Section


Warnings

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.

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

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

Ask a doctor before use if you have liver disease

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.

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
  • Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children

Dosage & Administration Section


Directions
  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last
  • do not take more than 6 tablets (3,000) mg in 24 hours, unless directed by a doctor
  • swallow whole - do not crush, chew or dissolve
  • do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: do not use

Storage And Handling Section


Other Information
  • Store in a cool dry place
  • Store below 30°C (86°F)

Inactive Ingredient Section


Inactive Ingredients

Hydroxypropyl methylcellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized starch, Purified Water, Titanium Dioxide, Vanillin

Otc - Questions Section


Questions or Comments? Call 1-800-721-5072

Package Label.principal Display Panel


Tempra

ACETAMINOPHEN 500 mg

PAIN RELIEVER / FEVER REDUCER

Extra Strength

Adults

20 Tablets

See new warnings information

NDC 64613-5700-1

Contains no Aspirin

Tamper evident: product is sealed in buler package for your protection. Do not use if carton is damaged or if printed seal on buler is broken or missing.

Lot:

Expiration Date:



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."

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"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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