FDA Label for Ecotrin

Active Ingredient

(in each tablet)

Aspirin (NSAID) *81mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains due to:
  • headache
    
  • minor arthritis pain
    
  • toothache
    
  • menstrual pain
    
  • 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
  
• 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, 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

• adults and children 12 years of age and 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

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

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 PANELThe Aspirin Regimen That’s Smart For Your HeartEcotrin®Safety Coated Aspirin (NSAID) Pain Reliever#1 CARDIOLOGIST Recommended Aspirin81 mg Low Strength150 Tablets - ecotrin low strength 01