Label: ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release
- NDC Code(s): 57237-349-10, 57237-349-12
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 4, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
- PURPOSE
- Uses
-
Warnings
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:
- hives
- shock
- 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
- Do not use
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
- you experience any of the following signs of stomach
bleeding: - feel faint
- has bloody or black stools
- vomits blood
- has stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever get worse or lasts for more than 3 days
- redness or swelling is present in the painful area
- new symptoms appear. These could be sign of a serious condition.
- you experience any of the following signs of stomach
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
-
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over:
- take 4 to 8 tablets every 4 hours while symptoms last
- do not take more than 48 tablets in 24 hours unless directed by doctor
- children under 12 years: ask a doctor
Other information
- store at room temperature 15-30°C (59-86°F)
- Inactive ingredients
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ADULT LOW DOSE ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-349 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) sodium hydroxide (UNII: 55X04QC32I) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code 81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57237-349-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 07/09/2025 2 NDC:57237-349-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/09/2025 Labeler - Rising Pharma Holdings, Inc. (116880195) Registrant - Elysium Pharmaceuticals Ltd (915664486) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceuticals Ltd 915664486 manufacture(57237-349) , analysis(57237-349) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceuticals Ltd 863182240 label(57237-349) , pack(57237-349)

