Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet
- NDC Code(s): 48433-129-01
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 69168-288
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 8, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses
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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 three (3) or more alcoholic drinks every day while using this
- take more or for a longer time than directed.
- Do not use
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if
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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,
- Keep out of reach of childen.
- Directions
- Other information:
- Inactive ingredients:
- 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:48433-129(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:48433-129-01 100 in 1 BOX 11/01/2022 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M343 11/01/2022 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 repack(48433-129) , relabel(48433-129)