FDA Label for Aspirin EC

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

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.

  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

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 - 2440

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.