Label: ASPIRIN 325- aspirin tablet, coated
- NDC Code(s): 0363-0691-12
- 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 August 5, 2020
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- Active ingredient (in each caplet)
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
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- are age 60 or older
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
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
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:
- vomit blood
- feel faint
- have bloody or black stools
- 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® Regular
Strength Aspirin 325 mg Safety
Coated Caplets active ingredient††
325 mg / PAIN RELIEVER (NSAID)
**Talk to your doctor or other healthcare provider before using this product for your heart.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
†† This product is not manufactured or
distributed by Bayer HealthCare LLC,
owner of the registered trademark
Bayer® Regular Strength Aspirin 325 mg
Safety Coated Caplets.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com ©2018 Walgreen Co.
INGREDIENTS AND APPEARANCE
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0691 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 POWDERED CELLULOSE (UNII: SMD1X3XO9M) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW Score no score Shape OVAL Size 15mm Flavor Imprint Code 691 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0691-12 1 in 1 CARTON 07/01/2017 1 100 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 NOT FINAL part343 07/01/2017 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(0363-0691) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0363-0691) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0691) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0691)