Label: ASPIRIN REGULAR STRENGTH- aspirin tablet, coated
- NDC Code(s): 49035-370-03, 49035-370-12
- Packager: EQUATE (Wal-Mart Stores, 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 October 20, 2021
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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
- 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
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:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
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 Ecotrin® active ingredient**
Pain reliever (NSAID)
- Protects against stomach upset
**This product is not manufactured or distributed by Prestige Brand, Inc., distributor of Ecotrin®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
†This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Ecotrin®.
DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
PRODUCT OF CHINA
- Package Label
INGREDIENTS AND APPEARANCE
ASPIRIN REGULAR STRENGTH
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-370 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-370-03 1 in 1 BOX 10/25/2013 01/05/2024 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-370-12 1 in 1 BOX 10/25/2013 01/05/2024 2 125 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 final part343 10/25/2013 01/05/2024 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)