ASPIRIN LOW DOSE ENTERIC COATED - aspirin tablet, coated 
Time-Cap Labs, Inc

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DRUG FACTS

Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug

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 • you have lost a lot of
fluid due to vomiting or diarrhea
Ask a doctor or pharmacist before use if you are
• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug

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

not use • if you are allergic to aspirin or any other
pain reliever/fever reducer

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.

Ask a doctor or pharmacist before use if you are
• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug

Uses • temporarily relieves minor aches and pains
• for other uses, see your doctor, but do not use for more
than 10 days without consulting your doctor because
serious side effects may occur

NDC 49483-387-10LOW DOSE ASPIRIN REGIMEN ENTERIC safety Coated 1000 ENTERIC COATED TABLETS SEE NEW   81MG WARNINGS INFORMATION Pain Reliever(NSAID) New Improved Formula

ASPIRIN  LOW DOSE ENTERIC COATED aspirin   tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-387 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspirin (aspirin) aspirin 81 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code embossed;upper;heart;lower;plain Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-387-12 120 TABLET In 1 BOTTLE, PLASTIC None 2 49483-387-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	06/28/2010

Labeler - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Operations
Time-Cap Labs, Inc		037052099	manufacture

Revised: 07/2010Time-Cap Labs, Inc