DrugCite

REGULAR STRENGTH ASPIRIN EC  - aspirin tablet, delayed release 
Major Pharmaceuticals Inc

DRUG FACTS

Active ingredient (in each tablet)                  Purpose

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

*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

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

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

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, 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 (1-800-222-1222).

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 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

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

IMAGE OF BOX

REGULAR STRENGTH ASPIRIN EC 
aspirin  tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-2011
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (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 orange Score no score
Shape ROUND Size 11mm
Flavor Imprint Code T
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0904-2011-59 100 TABLET In 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 09/09/2011

Labeler - Major Pharmaceuticals Inc (191427277)
Registrant - Time Cap Labs Inc (037052099)
Establishment
Name Address ID/FEI Operations
Time Cap Labs Inc 037052099 manufacture
Revised: 09/2011Major Pharmaceuticals Inc