ECOTRIN- aspirin tablet, coated 
GlaxoSmithKline Consumer Healthcare LP

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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Drug Facts

Active ingredient (in each tablet) (Low Strength)

Aspirin (NSAID)* 81mg

*nonsteroidal anti-inflammatory drug

Active ingredient (in each tablet) (Regular Strength)

Aspirin (NSAID)* 325mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains due to:
headache
menstrual pain
minor arthritis pain
muscle pain
toothache
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
facial swelling
shock
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 warnings 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 (Low Strength)

adults and children 12 years of age or 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

Directions (Regular Strength)

adults and children 12 years of age or 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 (Low Strength)

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 black ink.

Inactive ingredients (Regular Strength)

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 1-800-245-1040 (English/Spanish) weekdays

ECOTRIN is a registered trademark of the GlaxoSmithKline group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in Thailand

www.ecotrin.com

Principal Display Panel (Low Strength)

 NDC 0135-0117-88

Ecotrin®

Safety Coated Aspirin (NSAID)Pain Reliever

The Aspirin Regimen That's Smart For Your Heart

#1 CARDIOLOGIST Recommended Aspirin

81mg Low Strength

365 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

VALUE SIZE!

©2011 GlaxoSmithKline

100183XB

Ecotrin 81 mg 365 count carton

Principal Display Panel (Regular Strength)

NDC 0135-0014-30

Ecotrin®

Safety Coated Aspirin (NSAID)Pain Reliever

The Aspirin Regimen That's Smart For Your Heart

#1 CARDIOLOGIST Recommended Aspirin

325mg Regular Strength

300 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

VALUE SIZE!

©2011 GlaxoSmithKline

100198XB

Ecotrin 325 mg carton
ECOTRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
EDETIC ACID 
FD&C YELLOW NO. 6 
GLYCERYL MONOSTEARATE 
HYPROMELLOSES 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHYLPARABEN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
PROPYLPARABEN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code Ecotrin;Low
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0117-88365 in 1 BOTTLE
2NDC:0135-0117-0245 in 1 BOTTLE
3NDC:0135-0117-01150 in 1 BOTTLE
4NDC:0135-0117-871 in 1 CARTON
414 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/12/201007/31/2014
ECOTRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
EDETIC ACID 
FD&C YELLOW NO. 6 
GLYCERYL MONOSTEARATE 
HYPROMELLOSES 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHYLPARABEN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
PROPYLPARABEN 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code Ecotrin;Reg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0014-27125 in 1 BOTTLE
2NDC:0135-0014-30300 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/12/201006/30/2014
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 3/2013
Document Id: 5d739fc4-21a3-45b9-92f4-bdc5f6f8b0e6
Set id: a3696a69-2fda-4230-9834-0c7ba9b9e820
Version: 7
Effective Time: 20130308
 
GlaxoSmithKline Consumer Healthcare LP