Label: ASPICA (ASPIRIN)- aspirin tablet, delayed release

  • NDC Code(s): 49638-101-12
  • Packager: America Medic & Science, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 16, 2024

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

  • Aspirin Delayed-Release Tablets, USP 81 MG Low Dose Safety Coated Aspirin

    Drug Facts

  • Active ingredient

    Aspirin 81 mg (NSAID)**

    **nonsteroidal anti-inflammatory drug

  • Purpose

  • Uses

    • for the 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 other 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:

    • facial swelling
    • asthma (wheezing)
    • shock
    • hives
  • WARNINGS

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 problems
    • 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

    Do not use if you are allergic to aspirin or any other pain reliever/ fever reducer.

  • ASK DOCTOR

    Ask your doctor before use

    • 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, kidney disease or asthma
    • you are taking a diuretic
  • ASK DOCTOR/PHARMACIST

    Ask your doctor or pharmacist before use if you are taking a prescription drug for

    • gout
    • diabetes
    • arthritis
  • STOP USE

    Stop use and ask 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 a loss of hearing occurs
  • 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 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    Do not use this product if printed safety seal under cap is torn or missing.

  • ASK DOCTOR

    Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen.

  • DOSAGE & ADMINISTRATION

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • Other information

    • save carton for full directions and warnings
    • store at room temperature
  • Inactive ingredients

    Colloidal silicon dioxide, Croscarmellose sodium, Colloidal silicon dioxide, D&C Yellow #10 al lake, FD&C Yellow #6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    call 1-855-314-1850

  • PRINCIPAL DISPLAY PANEL

    Aspica 81 mg

  • INGREDIENTS AND APPEARANCE
    ASPICA (ASPIRIN) 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49638-101-121 in 1 CARTON09/16/2020
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/16/2020
    Labeler - America Medic & Science, LLC (071065464)
    Registrant - America Medic & Science, LLC (071065464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Invahealth116840615manufacture(49638-101) , analysis(49638-101) , pack(49638-101)