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Name:Aspirinlow Dose Enteric Coated
Manufacturer:Time-cap Labs, Inc
Category:Over-the-counter (OTC) Marketed Drugs


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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

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

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.

IMAGE OF BULK LABELEnter section text here


ASPIRIN  LOW DOSE ENTERIC COATED
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-390
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (aspirin) aspirin 81 mg
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code embossed;A;lower;plain
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-390-00 100000 TABLET ( TABLET) in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 07/16/2010

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

Revised: 07/2010 Time-Cap Labs, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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