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.

  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Drug Facts

    Active ingredient (in each tablet)                        Purpose
    Aspirin 81 mg (NSAID)*..................................Pain reliever
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • Uses

    • temporary relief of minor aches and pains or as recommended by your doctor.
      Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.
  • 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

    • if you are allergic to aspirin, or any other pain reliever/fever reducer
  • ASK DOCTOR

    Ask a doctor before use if 

    • You have asthma 
    • 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
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug
  • 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.
  • PREGNANCY OR BREAST FEEDING

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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

    Colloidal silicon dioxide, croscarmellose sodium, D&C yellow 10, iron oxide yellow 6, lactose, methacrylic acid and ethyl acrylate copolymer,
    microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate

  • QUESTIONS

    Questions and comments? Call 1-844-474-7464

    This product is not manufactured or distributed by Bayer, owner of the registered trademark Aspirin Regimen BAYER®

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    Made in India

    Mfg. Lic. No.: G/25/1362

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Adult Low Dose
    Aspirin
    81 mg

    NDC 57237-349-10

    1,000 Tablets

    aspirin-81mg-1000ct

  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-349
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-349-12120 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
    2NDC:57237-349-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/04/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/09/2025
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Registrant - Elysium Pharmaceuticals Ltd (915664486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd915664486manufacture(57237-349) , analysis(57237-349)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd863182240label(57237-349) , pack(57237-349)