FDA Label for Regular Strength Aspirin Ec

Otc - Active Ingredient

Active ingredient (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose
Pain reliever

Indications & Usage

Uses

• •for the temporary relief of minor aches and pains due to
  • •headache
  • •colds
  • •muscle pain
  • •menstrual pain
  • •toothache
  • •minor pain of arthritis
  • •or as directed by your doctor
    
  
  

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 or 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 inclue:

• •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 are allergic to aspirin or any other pain reliever/fever reducer
  

Otc - Ask Doctor

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
• •you have not been drinking fluids
  

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

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

Otc - Stop Use

Stop use and ask a doctor if

• •you experience any of the following signs of stomach bleeding:
  • •feel faint
  • •have bloody or black stools
  • •vomit blood
  • •have 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 (1-800-222-1222).

Dosage & Administration

Directions

• •drink a full glass of water with each dose
• •adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
• •children under 12 years: consult a doctor
  

Storage And Handling

Other information

• •store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• •use by expiration date on package
  

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? To Report Adverse Drug Event Call: (800) 616-2471