Label: ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 41163-157-12, 41163-157-14, 41163-157-17
- Packager: SUPERVALU INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 11, 2018
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- Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*Close
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducerClose
- minor pain of arthritis
- muscle pain
- menstrual pain
- pain and fever of colds
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:
- asthma (wheezing)
- facial swelling
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]
- take more or for a longer time than directed
- 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 asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- 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
- 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
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- 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
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
- children under 12 years: ask a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- use by expiration date on package
- Inactive ingredients
corn starch, hypromellose, polyethylene glycol, propylene glycolClose
- Questions or comments?
- Principal Display Panel
Genuine Bayer® Aspirin
aspirin 325 mg
pain reliever/fever reducer
300 coated tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DOES NOT CONTAIN GLUTEN
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344
USA Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com.
- INGREDIENTS AND APPEARANCE
aspirin tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-157 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code ASPIRIN;44;157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-157-12 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2006 12/07/2020 2 NDC:41163-157-14 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2006 12/07/2020 3 NDC:41163-157-17 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2006 12/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 02/10/2006 12/07/2020 Labeler - SUPERVALU INC. (006961411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41163-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(41163-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(41163-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(41163-157)