Label: ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever

  • 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 headaches or symptoms needing immediate relief.
  • Warnings

    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

    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.

    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 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 and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have 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 gets worse or lasts for more than 3 days
    • redness or swelling present in the painful area
    • new symptoms occur

    These could be sign 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.

    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 a doctor
    • children under 12 years:ask a doctor
  • Storage Conditions

    • store at room temperature 20-25ºC (68-77ºF)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    Starch, Povidone, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl acrylate Co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6.

  • Questions or comments?

    Please contact us at info@heivy.com

  • Distributed by:

    Heivy ®of Felicific Inc

    Queens, NY 11435

    www.heivy.com

    Made in the USA

  • PRINCIPAL DISPLAY PANEL

    NDC 84014-531-03

    Heivy ®

    Compare to Bayer ®Low Dose Aspirin active ingredients*

    Adult Low Dose Aspirin Delayed Release Tablets, 81 mg

    Pain Reliever (NSAID)

    Enteric Coated

    300 Tablets

    *This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer ®Low Dose Aspirin.

    Aspirin

  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84014-531
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code A1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84014-531-03300 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2024
    Labeler - FELICIFIC INC. (081178920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Pharma USA LLC080804485manufacture(84014-531)