Regular Strength Aspirin EC

H.J. Harkins Company, Inc.
MAJOR PHARMACEUTICALS INC

DRUG FACTS

FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient (in each tablet)                  Purpose

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

*nonsteroidal anti-inflammatory drug

Purpose

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
  

• hives
• facial swelling
• shock
• asthma (wheezing)

• 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 are allergic 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
• you have not been drinking fluids
  

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
  

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
  

If pregnant or breast-feeding,
Keep out of reach of children.
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
  

Other information

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

Inactive ingredients
Questions? (800) 616-2471

Repacked by:

Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE Product Information Product Type Human otc drug label Item Code (Source) NDC:52959-018(NDC:0904-2013) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspirin ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A cellulose, microcrystalline Mineral Oil polysorbate 80 SILICON DIOXIDE DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE talc titanium dioxide TRIETHYL CITRATE Product Characteristics Color Size Imprint Code Shape orange 11 mm T ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-018-14 14 in 1 BOTTLE 2 NDC:52959-018-20 20 in 1 BOTTLE 3 NDC:52959-018-24 24 in 1 BOTTLE 4 NDC:52959-018-30 30 in 1 BOTTLE 5 NDC:52959-018-40 40 in 1 BOTTLE 6 NDC:52959-018-60 60 in 1 BOTTLE 7 NDC:52959-018-80 80 in 1 BOTTLE 8 NDC:52959-018-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part343 2011-09-09