FDA Label for Enteric Coated Aspirin

Otc - Active Ingredient

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever

Indications & Usage

Uses

temporarily relieves

• headache
• muscle pain
• menstrual pain
• toothache
• minor pain of arthritis
• pain and fever of colds
  

Warnings

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 the user

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• takes more or for a longer time than directed
• has 3 or more alcoholic drinks every day while using this product
• is age 60 or older
  

Otc - Do Not Use

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Otc - Ask Doctor

Ask a doctor before use if

• stomach bleeding warning applies to user
• user has a history of stomach problems such as heartburn
• user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
• user is taking a diuretic
• user has asthma
• user has not been drinking fluids
  

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if user is

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug
• under a doctor's care for any serious condition
  

Otc - Stop Use

Stop use and ask a doctor if

• user experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs
    
  
  

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.

Dosage & Administration

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

• adults and children 12 years and over: 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
• children under 12 years: ask a doctor
  

Storage And Handling

Other information

• store at 20° - 25°C (68° - 77°F)
  

Inactive Ingredient

Inactive ingredients

corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Otc - Questions

Questions or comments?

call

1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

Principal Display Panel

Aspirin EC 325mg (5gr) - a0f84fac 3f7c 45c0 a2e8 ce39fb2bd630 01