Label: ASPIRIN CHEWABLE, LOW DOSE- aspirin tablet, chewable
- NDC Code(s): 41163-797-07
- Packager: SUPERVALU INC.
- 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 23, 2021
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- Active ingredient (in each chewable 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
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
- have had stomach ulcers or bleeding problems
- 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
- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
- 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:
- vomit blood
- have bloody or black stools
- feel faint
- 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.
- drink a full glass of water with each dose
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
compare to Bayer®
Chewable Low Dose Aspirin
aspirin 81 mg
pain reliever (NSAID)
• aspirin regimen
TALK TO YOUR DOCTOR OR OTHER HEALTHCARE PROVIDER BEFORE USING THIS PRODUCT
FOR YOUR HEART. CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.
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 AG, owner of the registered trademark Bayer®
chewable Low Dose Aspirin.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
INGREDIENTS AND APPEARANCE
ASPIRIN CHEWABLE, LOW DOSE
aspirin tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-797 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 STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color pink Score no score Shape ROUND Size 8mm Flavor CHERRY Imprint Code 44;397 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-797-07 1 in 1 CARTON 09/04/2001 1 36 in 1 BOTTLE; 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 09/04/2001 Labeler - SUPERVALU INC. (006961411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(41163-797) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(41163-797) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(41163-797) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(41163-797)