Label: ASPIRIN tablet, coated
- NDC Code(s): 36800-968-05, 36800-968-12, 36800-968-50
- Packager: TOP CARE (Topco Associates LLC)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 November 28, 2022
If you are a consumer or patient please visit this version.
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- 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 have asthma
- you are taking a diuretic
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
- have bloody or black stools
- vomit blood
- 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
- Inactive ingredients
- Questions or comments?
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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.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
- Product Label
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-968 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 SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code E Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-968-12 1 in 1 BOX 04/01/2020 1 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:36800-968-50 1 in 1 CARTON 04/01/2020 2 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:36800-968-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2020 Labeler - TOP CARE (Topco Associates LLC) (006935977)