NDC 52959-018 Regular Strength Aspirin Ec

Otc - Active Ingredient

Active ingredient (in each tablet)                  PurposeAspirin 325 mg (NSAID*).............................Pain reliever*nonsteroidal anti-inflammatory drug

Otc - Purpose

PurposePain reliever

Indications & Usage

• Usesfor the temporary relief of minor aches and pains due toheadachecoldsmuscle painmenstrual paintoothacheminor pain of arthritisor as directed by your doctor

Warnings

• WarningsReye'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:hivesfacial swellingshockasthma (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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed

Otc - Do Not Use

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

Otc - Ask Doctor

• Ask a doctor before use ifstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have not been drinking fluids

Otc - Ask Doctor/Pharmacist

• Ask a doctor or pharmacist before use if you aretaking a prescription drug for diabetes, gout, or arthritistaking any other drugsunder a doctor's care for any serious condition

Otc - Stop Use

• Stop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appearringing in the ears or a loss of hearing occurs

Otc - Pregnancy Or Breast Feeding

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

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

• Directionsdrink a full glass of water with each doseadults 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 doctorchildren under 12 years: consult a doctor

Storage And Handling

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

Inactive Ingredient

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

Questions? To Report Adverse Drug Event Call: (800) 616-2471Repacked by:H.J. Harkins Company, Inc.Nipomo, CA 93444