Label: ECOTRIN- aspirin tablet, coated

  • NDC Code(s): 63029-301-01, 63029-301-07, 63029-301-08, 63029-301-14, view more
    63029-301-45, 63029-301-65
  • Packager: Medtech Products Inc.
  • 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 July 16, 2012

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    (in each tablet)

    Aspirin (NSAID) *81mg

    *nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever

    Close
  • Uses

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

    • or as recommended by a doctor
    Close
  • 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.

    Close
  • Directions

    • adults and children 12 years of age and 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
    Close
  • Other information

    • Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
    • store below 25ºC (77ºF)
    Close
  • Inactive ingredients

    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 ink.

    Close
  • Questions or comments?

    call toll-free 1-866-255-5202 (English/Spanish) weekdays

    Close
  • PRINCIPAL DISPLAY PANEL

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

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

    Close
  • INGREDIENTS AND APPEARANCE
    ECOTRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-301
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 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 8mm
    Flavor Imprint Code Ecotrin;Low
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-301-07 1 in 1 BOX
    1 7 in 1 BLISTER PACK
    2 NDC:63029-301-08 1 in 1 CARTON
    2 8 in 1 BLISTER PACK
    3 NDC:63029-301-01 1 in 1 BOX
    3 150 in 1 BOTTLE, PLASTIC
    4 NDC:63029-301-14 1 in 1 CARTON
    4 14 in 1 BOTTLE, PLASTIC
    5 NDC:63029-301-45 45 in 1 BOTTLE, PLASTIC
    6 NDC:63029-301-65 365 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)
    Close