Label: LOW DOSE ASPIRIN- aspirin tablet, coated
- NDC Code(s): 76162-980-05, 76162-980-12, 76162-980-50
- Packager: Topco Associates
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 11, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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 his 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 stool
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever get 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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO BAYER® LOW DOSE ASPIRIN ACTIVE INGREDIENT≠
LOW DOSE
ASPIRIN REGIMEN
Aspirin 81 mg
PAIN RELIEVER (NSAID)
Safety Coated††
TABLETS
†Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone.
††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
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
- Product Label
-
INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-980 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) METHACRYLIC ACID (UNII: 1CS02G8656) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SOYBEAN (UNII: L7HT8F1ZOD) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-980-50 1 in 1 BOX 08/01/2023 1 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:76162-980-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2023 3 NDC:76162-980-12 1 in 1 BOX 08/01/2023 3 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/01/2023 Labeler - Topco Associates (006935977)