Label: CHEWABLE ASPIRIN- aspirin tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 52124-0012-1 - Packager: Genuine First Aid LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 5, 2019
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- Official Label (Printer Friendly)
- Active Ingredient
- 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.
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.
- Do not use
- Ask a doctor before use if you have:
- Stop use and ask a doctor if:
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
- STORAGE AND HANDLING
- Inactive Ingredients
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHEWABLE ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0012 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 (UNII: FST467XS7D) SODIUM CATION (UNII: LYR4M0NH37) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) Product Characteristics Color orange (ORANGE) Score no score Shape ROUND Size 11mm Flavor Imprint Code ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0012-1 2 in 1 PACKAGE; Type 0: Not a Combination Product 04/02/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 04/02/2010 Labeler - Genuine First Aid LLC (619609857)