Label: ASPIRIN ENTERIC COATED- aspirin 325 mg tablet
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- NDC Code(s): 69168-400-17, 69168-400-30
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2019
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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 you are allergic to aspirinor any other pain reliever/fever reducer
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 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.
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
- Keep out of reach of children
- Directions
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC COATED
aspirin 325 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-400 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ALUMINUM OXIDE (UNII: LMI26O6933) POLYSORBATE 80 (UNII: 6OZP39ZG8H) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) Product Characteristics Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-400-30 1 in 1 CARTON 12/18/2014 03/31/2024 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-400-17 300 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2022 03/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/18/2014 03/31/2024 Labeler - Allegiant Health (079501930)
