OTC Medication Information: Ecotrin

ECOTRIN- aspirin tablet, coated
Medtech Products Inc.

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 Facts

Active ingredient

(in each tablet)

Aspirin (NSAID) *81mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • minor arthritis pain
    • toothache
    • menstrual pain
    • the common cold

  • 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 ▪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.
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • 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 (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 doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

  • Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.

  • store at 25°C (77°F); exclusions permitted between 15°C-30°C (59°F-86°F)

  • avoid excessive heat and humidity

  • see end flap for expiration date and lot number

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

32 Enteric Coated Tablets

PRINCIPAL DISPLAY PANEL

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

32 Enteric Coated Tablets
PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 32 Enteric Coated Tablets
ECOTRIN aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-311
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
Polyvinyl Acetate Phthalate
PROPYLENE GLYCOL
SODIUM ALGINATE
SODIUM BICARBONATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
SHELLAC
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code Ecotrin;Low
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-311-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 150 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63029-311-01)
2 NDC:63029-311-14 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 14 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63029-311-14)
3 NDC:63029-311-65 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 365 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63029-311-65)
4 NDC:63029-311-75 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 175 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63029-311-75)
5 NDC:63029-311-32 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
5 32 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63029-311-32)
6 NDC:63029-311-45 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
6 45 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63029-311-45)
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)

Revised: 04/2020 Medtech Products Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.