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.

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Ecotrin Low Strength

Drug Facts

Active ingredient

(in each tablet)

Aspirin (NSAID) *81mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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

Other information

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.

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
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

ECOTRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code Ecotrin;Low
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-301-071 in 1 BOX
17 in 1 BLISTER PACK
2NDC:63029-301-081 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:63029-301-011 in 1 BOX
3150 in 1 BOTTLE, PLASTIC
4NDC:63029-301-141 in 1 CARTON
414 in 1 BOTTLE, PLASTIC
5NDC:63029-301-4545 in 1 BOTTLE, PLASTIC
6NDC:63029-301-65365 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)

Revised: 7/2012
Document Id: ae512c15-44c0-4c87-8fee-1d144546e121
Set id: f950d4eb-39b9-4ef7-b5f3-0cf45d4d6bc0
Version: 2
Effective Time: 20120716
 
Medtech Products Inc.