Label: ASPIRIN tablet, coated
- NDC Code(s): 0363-0587-14, 0363-0587-32
- Packager: Walgreen Company
- 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.
Updated October 7, 2020
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- Active ingredient (in each tablet)
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:
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- take other drugs containing prescriptions or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
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
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
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Other information
- Inactive ingredients
- Questions or comments?
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Compare to Bayer® Low Dose
Aspirin active ingredient††
Dye-Free Aspirin 81
81 mg / PAIN RELIEVER (NSAID)
DYE FREE LOW DOSE
120 ENTERIC COATED
** Talk to your doctor or other healthcare provider before using this product for your heart.
Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD. DEERFIELD, IL 60015
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INGREDIENTS AND APPEARANCE
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0587 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SHELLAC (UNII: 46N107B71O) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) METHACRYLIC ACID (UNII: 1CS02G8656) SODIUM LAURYL SULFATE (UNII: 368GB5141J) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0587-32 1 in 1 BOX 03/18/2009 1 120 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0587-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/18/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 03/18/2009 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0587) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 MANUFACTURE(0363-0587) , PACK(0363-0587) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0363-0587)