Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet
- NDC Code(s): 69168-288-01, 69168-288-36
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 21, 2018
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- Active ingredient
- Purpose
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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 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 aspirinor 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 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 stools, 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
- Keep Out of Reach of Children
- Directions
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN CHEWABLE
aspirin 81 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-288 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength DEXTRATES (UNII: G263MI44RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange Score no score Shape ROUND Size 7mm Flavor ORANGE Imprint Code AZ013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-288-36 1 in 1 CARTON 12/18/2014 1 36 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-288-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014 06/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/18/2014 Labeler - Allegiant Health (079501930)
