Label: LOW DOSE ASPIRIN CHEWABLE- aspirin tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 69517-136-30 - Packager: Healthlife of USA
- Category: HUMAN OTC DRUG LABEL
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 October 9, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- 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 behaviour 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
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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
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Other information
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN CHEWABLE
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-136 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DEXTRATES (UNII: G263MI44RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) ORANGE (UNII: 5EVU04N5QU) STARCH, CORN (UNII: O8232NY3SJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code TCL;334 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-136-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/09/2017 Labeler - Healthlife of USA (079656178) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc. 037052099 manufacture(69517-136)