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Generic: aspirin


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aspirin 325 mg - t round orange

aspirin 325 mg delayed release oral tablet - t round orange

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Otc - Active Ingredient Section


Active ingredient (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION


Purpose Pain reliever

Indications & Usage Section


Uses
  • •for the temporary relief of minor aches and pains due to
    • oheadache
    • ocolds
    • omuscle pain
    • omenstrual pain
    • otoothache
    • ominor pain of arthritis
  • •or as directed by your doctor

Warnings Section


Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may inclue:
  • •hives
  • •facial swelling
  • •shock
  • •asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • •are age 60 or older
  • •have had stomach ulcers or bleeding problems
  • •take a blood thinning (anticoagulant) or steroid drug
  • •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • •have 3 or more alcoholic drinks every day while using this product
  • •take more or for a longer time than directed

Otc - Do Not Use Section


Do not use
  • •if you are allergic to aspirin or any other pain reliever/fever reducer

Otc - Ask Doctor Section


Ask a doctor before use if
  • •stomach bleeding warning applies to you
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • •you are taking a diuretic
  • •you have asthma
  • •you have not been drinking fluids

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if you are
  • •taking a prescription drug for diabetes, gout, or arthritis
  • •taking any other drugs
  • •under a doctor's care for any serious condition

Otc - Stop Use Section


Stop use and ask a doctor if
  • •you experience any of the following signs of stomach bleeding:
    • ofeel faint
    • ohave bloody or black stools
    • ovomit blood
    • ohave stomach pain that does not get better
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present in the painful area
  • •any new symptoms appear
  • •ringing in the ears or a loss of hearing occurs

Otc - Pregnancy Or Breast Feeding Section


If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Dosage & Administration Section


Directions
  • •drink a full glass of water with each dose
  • •adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • •children under 12 years: consult a doctor

Storage And Handling Section


Other information
  • •store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • •use by expiration date on package

Inactive Ingredient Section


Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Otc - Questions Section


Questions? To Report Adverse Drug Event Call: (800) 616-2471

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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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