Label: ASPIRIN tablet, delayed release
- NDC Code(s): 69842-927-14, 69842-927-57
- Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 11, 2024
If you are a consumer or patient please visit this version.
- 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
- shock
- facial swelling
- 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 3 or more alcoholic drinks every day while using this product
- 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]
- 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
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- stomach bleeding warning applies to you
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- 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
- feel faint
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
- Questions or comments?
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Principal Display Panel
♥︎CVS Health
Compare to the active ingredient in Ecotrin® Regular Strength†
Coated TabletsRegular Strength
Aspirin
325 mg
Pain reliever (NSAID)Arthritis
Pain Relief‡
‡Temporarily relieves
minor pain of arthritisActual Size
Safety
Coated125 ENTERIC
COATED TABLETSPackage Contains
One BottleTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING†This product is not manufactured or distributed by
Medtech Products Inc., owner of the registered trademark
Ecotrin® Regular Strength. 50844 REV0122B22757Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy V-11112
CVS 44-227
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-927 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-927-57 1 in 1 CARTON 03/01/2019 1 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69842-927-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/01/2019 Labeler - CVS PHARMACY (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(69842-927) , pack(69842-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(69842-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(69842-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(69842-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(69842-927) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(69842-927)