FDA Label for Adult Low Dose Enteric Coated Aspirin

Active Ingredient (In Each Tablet)

Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains
• ask your doctor about other uses for aspirin

Warnings

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

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 and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Reye's Syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy Alert:

• hives
• facial swelling
• asthma (wheezing)
• shock
Stomach bleeding warning:

• 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
  

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

Ask a doctor before use if

• the stomach bleeding warning applies to you
• you are taking a diuretic
• you have a history of stomach problems, such as heartburn
• you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma



Ask a doctor or pharmacist before use if you are

• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
  
• taking a prescription drug for diabetes, gout or arthritis



Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
• an allergic reaction occurs. Seek medical help right away
• pain gets worse or lasts more than 10 days
• redness or swelling is present
  
• fever gets worse or lasts more than 3 days
• any new symptoms occur
  
• ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,

Otc - Keep Out Of Reach Of Children

In case of overdose , get medical help or contact a Poison Control Center right away. Keep out of reach of children.

Directions

• drink a full glass of water with each dose
• swallow whole, do not chew or crush
  
• do not exceed recommended dose
• adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
• children under 12 years: ask a doctor

Other Information

• store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
• for institutional use only

Inactive Ingredients

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.