FDA Label for Leader Low Dose Aspirin

Active Ingredient (In Each Tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Indications & Usage

• for the temporary relief of minor aches and pains or as recommneded by your doctor
• ask your doctor about other uses for this product

Warning

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 and 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

• facial swelling
• shock
• hives
• 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
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• take more or for a longer time than directed
• have had stomach ulcers or bleeding problems
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do Not Use

• if you are allergic to aspirin or any other pain reliever/fever reducer
• this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask A Doctor Before Use If

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

• gout
• diabetes
• 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
• any new symptoms occur
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• ringing in the ears or loss of hearing occurs

These could be signs of a serious illness.

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.  

Keep Out Of Reach Of Children.

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

Directions

• drink a full glass of water with each dose

adults and children 12 years and over	take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years	consult a doctor

Other Information

• store at room temperature (15⁰-30⁰C)
• aviod excess heat and moisture

Inactive Ingredients

Corn starch, dextrose monohydrate, FD&c yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid

Questions Or Comments?

Adverse drug event call: 1-866-562-2756 

Package Label.Principal Display Panel

Compare to Bayer^® Chewable Low Dose Aspirin active ingredient***

Leader

Low Dose

Aspirin

81 mg

Chewable Orange

Pain Reliever (NSAID)

Orange Flavored