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Ecotrin Regular Strength (Medtech Products Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (63029-302-01) > 300 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 BOX (63029-302-02) > 125 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information

Complete Ecotrin Regular Strength Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    (in each tablet)

    Aspirin (NSAID) *325mg

    *nonsteroidal anti-inflammatory drug


  • Purpose

    Pain reliever


  • Uses

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

    • adults and children 12 years of age and 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 25ºC (77ºF)

  • Inactive ingredients

    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 1-866-255-5202 (English/Spanish) weekdays


  • PRINCIPAL DISPLAY PANEL

    The Aspirin Regimen That’s Smart For Your Heart
    Ecotrin®
    Safety Coated Aspirin (NSAID) Pain Reliever
    #1 CARDIOLOGIST Recommended Aspirin
    325 mg Regular Strength
    125 Tablets

    PRINCIPAL DISPLAY PANEL
The Aspirin Regimen That’s Smart For Your Heart
Ecotrin
Safety Coated Aspirin (NSAID) Pain Reliever
#1 CARDIOLOGIST Recommended Aspirin
325 mg Regular Strength
125 Tablets


  • INGREDIENTS AND APPEARANCE
    ECOTRIN REGULAR STRENGTH 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-302
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code Ecotrin;Reg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-302-01 1 in 1 CARTON
    1 300 in 1 BOTTLE, PLASTIC
    2 NDC:63029-302-02 1 in 1 BOX
    2 125 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 06/01/2012
    Labeler - Medtech Products Inc. (122715688)