Label: ECOTRIN- aspirin tablet, coated

  • NDC Code(s): 63029-311-01, 63029-311-14, 63029-311-32, 63029-311-45, view more
    63029-311-65, 63029-311-75
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each tablet)

    Aspirin (NSAID) *81mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pain due to:
      • headache
      • minor arthritis pain
      • toothache
      • muscle pain
      • menstrual pain
      • colds

    • or as recommended by your doctor
  • 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
    • facial swelling
    • shock
    • 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
    • take more or for a longer time than directed
    • 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

    Do not use

    if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have asthma
    • 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 ▪ gout ▪ diabetes ▪arthritis

    Stop use and ask a doctor if

    • 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

    • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
    • ringing in the ears or a loss of hearing occurs.
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present.

    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 at 20 weeks or later in 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.

  • 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, not to exceed 48 tablets in 24 hours unless directed by a doctorchildren under 12 years: do not use unless directed by a doctor
  • Other information

    • store at 25°C (77°F); exclusions permitted between 15°C-30°C (59°F-86°F)
    • see end flap for expiration date and lot number
    • avoid excessive heat and humidity
  • Inactive ingredients

    black iron oxide, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-866-255-5202 Ecotrin.com

  • PRINCIPAL DISPLAY PANEL


    Ecotrin®
    Safety Coated Aspirin (NSAID) Pain Reliever
    81 mg Low Strength 


    45 Tablets

    PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 45 Tablets

  • PRINCIPAL DISPLAY PANEL


    Ecotrin®
    Safety Coated Aspirin (NSAID) Pain Reliever
    81 mg Low Strength 


    150 Tablets

    PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 150 Tablets

  • PRINCIPAL DISPLAY PANEL


    Ecotrin®
    Safety Coated Aspirin (NSAID) Pain Reliever
    81 mg Low Strength 


    365 Tablets

    PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 365 Tablets

  • INGREDIENTS AND APPEARANCE
    ECOTRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code Ecotrin;Low
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-311-011 in 1 CARTON06/01/2012
    1150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:63029-311-141 in 1 CARTON06/01/2012
    214 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:63029-311-651 in 1 CARTON06/01/2012
    3365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:63029-311-751 in 1 CARTON06/01/2012
    4175 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:63029-311-321 in 1 CARTON06/01/2012
    532 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:63029-311-451 in 1 CARTON06/01/2012
    645 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2012
    Labeler - Medtech Products Inc. (122715688)
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