NEW CORRECT

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: Time-Cap Labs, Inc
NDC Code: 49483-046

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.

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 MG

NEW CORRECT  
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-046
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeTCL057
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-046-00100000 TABLET, DELAYED RELEASE (TABLET) in 1 CARTON
2NDC:49483-046-5115 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/06/2008
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs, Inc037052099manufacture

Revised: 01/2011
 
Time-Cap Labs, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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