ASPIRIN EC- aspirin tablet, coated 
Physicians Total Care, 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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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

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 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)

Directions (Regular Strength)

Other information

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



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

Principal Display Panel (Regular Strength)

NDC 54868-2440-0

Safety Coated Aspirin (NSAID)Pain Reliever

The Aspirin Regimen That's Smart For Your Heart

#1 CARDIOLOGIST Recommended Aspirin

81mg Low Strength

image of 81 mg package label

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.


__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __

NDC 54868-2405-3

Safety Coated Aspirin (NSAID)Pain Reliever

The Aspirin Regimen That's Smart For Your Heart

#1 CARDIOLOGIST Recommended Aspirin

325mg Regular Strength

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

image of 325 mg package label
ASPIRIN  EC
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2440(NDC:0135-0117)
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)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
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:54868-2440-0120 in 1 BOTTLE
2NDC:54868-2440-136 in 1 BOTTLE
3NDC:54868-2440-21000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/30/2000
ASPIRIN  EC
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2405(NDC:0135-0014)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 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)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code Ecotrin;Reg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2405-3100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/10/1993
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 2/2012
Document Id: 2400c707-fa24-452b-9002-333ae5901675
Set id: a961bef8-f864-4a24-a40e-3d9f22a0a75d
Version: 1
Effective Time: 20120227
 
Physicians Total Care, Inc.