FDA Label for Aspirin Chewable

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 or as recommended by your doctor

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 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:

• hives
• facial swelling
• asthma (wheezing)
• shock

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 three (3) or more alcoholic drinks every day while using this
• 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
• if you have ever had an allergic reaction to this product or any of its ingredients.

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

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

• an allergic reaction occurs. Seek medical help right away
• you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stool
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or 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 three (3) months of pregnancy unless specifically 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 Childen.

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.

Inactive Ingredients:

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium.

Principal Display Panel

Aspirin

81 mg

Chewable Tablet

Mfg: Allegiant Health

Lot:22A0131 Exp:09/06/24

PKG BY: Safecor Health

Woburn, MA

image description - product label