Ecotrin Regular Strength Tablet, Coated
FDA Label NDC 63029-302

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Ecotrin Regular Strength (NDC 63029-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 25°C (77°F)

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 Panelthe Aspirin Regimen That’s Smart For Your Heartecotrinsafety Coated Aspirin (nsaid) Pain Reliever#1 Cardiologist Recommended Aspirin325 mg Regular Strength125 Tablets (Ecotrin Regular 01)

Principal Display Panelthe Aspirin Regimen That’s Smart For Your Heartecotrinsafety Coated Aspirin (nsaid) Pain Reliever#1 Cardiologist Recommended Aspirin325 mg Regular Strength125 Tablets (Ecotrin Regular 01)

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