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Name:New Correct
Manufacturer:Time-cap Labs, Inc
Category:Over-the-counter (OTC) Marketed Drugs


NEW CORRECT   - bisacodyl tablet, delayed release 
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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Each tablet contains: Bisacodyl 5 mg

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are taking any other drug.  Take this product two or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Warnings:

Do not use for longer than one week; when abdominal pain, nausea or vomiting are present,; in children under 6 years of age; in persons who cannot swallow without chewing

Warnings:

Do not use for longer than one week; when abdominal pain, nausea or vomiting are present,; in children under 6 years of age; in persons who cannot swallow without chewing

Directions - DO NOT CHEW TABLETS

ADULTS AND CHILDREN 12 YEAR AND OVER - 1 -3 TABLETS ONCE A DAY

CHILDREN 6 TO 11 YEARS - 1 TABLET ONCE DAILY

CHILDREN UNDER 6 YEARS - ASK A DOCTOR


Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS:  Acacia, Calcium Sulfate Anhydrous, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D-C Red#7 Calcium Lake, Hypromellose Phthalate, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow, Kaolin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide, Triacetin

Uses:  Relieves occasional constipation; generally produces bowel movement in 6-12 hours.

Uses:  Relieves occasional constipation; generally produces bowel movement in 6-12 hours. Laxative

QUESTIONS OR COMMENTS? TIME-CAP LABS, INC. 7 MICHAEL AVE FARMINGDALE NY 11735

STOP USE AND ASK A DOCTOR IF:

You have rectal bleeding, you fail to have a bowel movement after use of this product.  THESE MAY INDICATE A SERIOUS CONDITION.

When using this product; do not take dose within one hour of taking an antacid or milk; you may experience abdominal discomfort, faintness and cramps.

BISACODYL D-R TABLETS 5 MG246RBULK LABEL


NEW CORRECT  
bisacodyl tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-046
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (BISACODYL) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA  
CALCIUM SULFATE ANHYDROUS  
CARNAUBA WAX  
SILICON DIOXIDE  
STARCH, CORN  
D&C RED NO. 7  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)  
FERROUS OXIDE  
FERROSOFERRIC OXIDE  
FERRIC OXIDE YELLOW  
KAOLIN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 400  
POVIDONE  
SHELLAC  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code TCL057
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-046-00 100000 TABLET, DELAYED RELEASE ( TABLET) in 1 CARTON None
2 NDC:49483-046-51 15 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 08/06/2008

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

Revised: 01/2011 Time-Cap Labs, Inc



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


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