Your browser does not support JavaScript! ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET [TIME-CAP LABS, INC]
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ASPIRIN LOW DOSE ENTERIC COATED (aspirin) tablet
[Time-Cap Labs, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Enter section text here

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49483-390
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (aspirin) aspirin81 mg
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code embossed;A;lower;plain
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-390-00100000 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/16/2010
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture

Revised: 7/2010
 
Time-Cap Labs, Inc

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