Label: ASPIRIN ENTERIC SAFETY COATED- aspirin tablet
- NDC Code(s): 69842-826-30, 69842-826-50
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 6, 2024
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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
- shock
- asthma (wheezing)
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 aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
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
- gout
- diabetes
- arthritis
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 stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
anhydrous lactose**, black iron oxide**, brown iron oxide**, carnauba wax**,corn starch**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, pharmaceutical ink**, polysorbate 80**, potassium hydroxide**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**
**contains one or more of these ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Bayer® Low Dose Aspirin†
Coated Tablets
Low Dose
Aspirin 81 mg
Pain reliever (NSAID)
- Safety coated±
- Aspirin regimen≠
TABLETS
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
±Talk to your doctor or other healthcare provider before using this product for your heart.
±Coating helps protect against stomach upset
†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com®
- Product Label
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INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC SAFETY COATED
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-826 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BROWN IRON OXIDE (UNII: 1N032N7MFO) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code E;T81;1;Heart Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-826-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2018 08/31/2025 2 NDC:69842-826-30 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2018 08/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/31/2018 08/31/2025 Labeler - CVS Pharmacy (062312574)