Regular Strength Aspirin EC (aspirin 325 mg) Dailymed

Generic: aspirin is used for the treatment of Arthritis, Rheumatoid Blood Coagulation Disorders Blood Platelet Disorders Cerebral Infarction Ischemic Attack, Transient Chickenpox Child, Preschool Fever Gout Hematemesis Hemorrhagic Disorders Infant Inflammation Melena Myocardial Infarction Nasal Polyps Osteoarthritis Pain Pre-Eclampsia Pregnancy Trimester, Third Rheumatic Fever

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COLOR: orange

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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

headache

colds

muscle pain

menstrual pain

toothache

minor 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:

feel faint

have bloody or black stools

vomit blood

have 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

Repackaging Information

Please reference the Product Characteristics section uled below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are uled below:

Count 325mg

30 67544-468-30

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by: Cookeville, TN 38506 20130604AW

Principal Display Panel - 325mg

NDC 67544-468 - Aspirin EC 325mg

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