Label: ASPIRIN EC- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 27, 2012

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  • Active ingredient (in each tablet) (Low Strength)

    Aspirin (NSAID)* 81mg

    *nonsteroidal anti-inflammatory drug

  • Active ingredient (in each tablet) (Regular Strength)

    Aspirin (NSAID)* 325mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • menstrual pain
      • minor arthritis pain
      • muscle pain
      • toothache
      • colds
    • or as recommended by a 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
    • 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • stomach bleeding warnings 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
    • you have asthma

    Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis

    Stop use and ask a doctor if

    • 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
    • any new symptoms appear
    • ringing in the ears or a loss of hearing occurs

    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 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 right away.

  • Directions (Low Strength)

    • adults and children 12 years of age or over: take 4 to 8 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
    • do not take more than 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years of age: ask a doctor
  • Directions (Regular Strength)

    • adults and children 12 years of age or over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
    • do not take more than 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years of age: ask a doctor
  • Other information

    • Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
    • store below 25°C (77°F)
  • Inactive ingredients (Low Strength)

    carnauba wax, colloidal silicon dioxide, EDTA, FD&C yellow#6, glyceryl monostearate, hypromellose, methacrylic acid copolymer, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, starch, stearic acid, talc, titanium dioxide, triethyl citrate. Printed with edible black ink.

  • Inactive ingredients (Regular Strength)

    carnauba wax, colloidal silicon dioxide, EDTA, FD&C yellow#6, glyceryl monostearate, hypromellose, methacrylic acid copolymer, methylparaben, microcrystalline cellulose, polysorbate 80, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid, talc, titanium dioxide, triethyl citrate. Printed with edible ink.

  • Questions or comments?

    call toll-free 1-800-245-1040 (English/Spanish) weekdays

    ECOTRIN is a registered trademark of the GlaxoSmithKline group of companies.

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108, Made in Thailand

    www.ecotrin.com



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • Principal Display Panel (Regular Strength)

    NDC 54868-2440-0

    Safety Coated Aspirin (NSAID)Pain Reliever

    The Aspirin Regimen That's Smart For Your Heart

    #1 CARDIOLOGIST Recommended Aspirin

    81mg Low Strength

    image of 81 mg package label

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.


    __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __

    NDC 54868-2405-3

    Safety Coated Aspirin (NSAID)Pain Reliever

    The Aspirin Regimen That's Smart For Your Heart

    #1 CARDIOLOGIST Recommended Aspirin

    325mg Regular Strength

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    image of 325 mg package label
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  EC
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2440(NDC:0135-0117)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code Ecotrin;Low
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2440-0120 in 1 BOTTLE
    2NDC:54868-2440-136 in 1 BOTTLE
    3NDC:54868-2440-21000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34311/30/2000
    ASPIRIN  EC
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2405(NDC:0135-0014)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code Ecotrin;Reg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2405-3100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34309/10/1993
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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