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Ecotrin by Medtech Products Inc.

Medically reviewed on Dec 22, 2017

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: Medtech Products Inc.
NDC Code: 63029-311

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.

Ecotrin Low Strength

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 




PRINCIPAL DISPLAY PANEL


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

#1 CARDIOLOGIST Recommended Aspirin

32 Enteric CoatedTablets

Actual Size

ECOTRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-311
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
Polyvinyl Acetate Phthalate 
PROPYLENE GLYCOL 
SODIUM ALGINATE 
SODIUM BICARBONATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeEcotrin;Low
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-311-011 BOTTLE, PLASTIC in 1 CARTON
1150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:63029-311-141 BOTTLE, PLASTIC in 1 CARTON
214 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:63029-311-651 BOTTLE, PLASTIC in 1 CARTON
3365 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:63029-311-751 BOTTLE, PLASTIC in 1 CARTON
4175 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:63029-311-321 BOTTLE, PLASTIC in 1 CARTON
532 TABLET, COATED in 1 BOTTLE, PLASTIC
6NDC:63029-311-451 BOTTLE, PLASTIC in 1 CARTON
645 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34306/01/2012
Labeler - Medtech Products Inc. (122715688)

 
Medtech Products Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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