Label: LOW STRENGTH CHEWABLE ASPIRIN- aspirin tablet, chewable
- NDC Code(s): 57896-911-36
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Active ingredient (in each tablet)
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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 your 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
- the 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 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,
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.
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INGREDIENTS AND APPEARANCE
LOW STRENGTH CHEWABLE ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-911 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 FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM (UNII: SB8ZUX40TY) DEXTRATES (UNII: G263MI44RU) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange Score no score Shape ROUND Size 7mm Flavor ORANGE Imprint Code AZ;013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-911-36 36 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/01/1995 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)