Label: REGULAR STRENGTH ASPIRIN EC- aspirin tablet, delayed release

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Active ingredient (in each tablet)                  Purpose

 

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

 

*nonsteroidal anti-inflammatory drug

 

Purpose
Pain reliever

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Uses

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for the temporary relief of minor aches and pains due to

 

 

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headache

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colds

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muscle pain

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menstrual pain

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toothache

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minor pain of arthritis

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or as directed by your doctor

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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 include:

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hives

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facial swelling

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shock

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asthma (wheezing)

 

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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are age 60 or older

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have had stomach ulcers or bleeding problems

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take a blood thinning (anticoagulant) or steroid drug

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take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

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have 3 or more alcoholic drinks every day while using this product

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take more or for a longer time than directed

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Do not use

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if you are allergic to aspirin or any other pain reliever/fever reducer

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Ask a doctor before use if

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stomach bleeding warning applies to you

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you have a history of stomach problems, such as heartburn

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you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

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you are taking a diuretic

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you have asthma

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you have not been drinking fluids

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Ask a doctor or pharmacist before use if you are

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taking a prescription drug for diabetes, gout, or arthritis

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taking any other drugs

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under a doctor's care for any serious condition

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Stop use and ask a doctor if

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you experience any of the following signs of stomach bleeding:

 

 

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feel faint

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have bloody or black stools

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vomit blood

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have stomach pain that does not get better

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pain gets worse or lasts more than 10 days

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fever gets worse or lasts more than 3 days

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redness or swelling is present in the painful area

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any new symptoms appear

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ringing in the ears or a loss of hearing occurs

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.

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Directions

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drink a full glass of water with each dose

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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

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children under 12 years: consult a doctor

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).

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

Product: 50090-3450

NDC: 50090-3450-1 30 TABLET, DELAYED RELEASE in a BOTTLE