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STIMULANT LAXATIVE by TIME CAP LABORATORIES, INC.

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: TIME CAP LABORATORIES, INC.
NDC Code: 49483-003

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.

In each tablet: Bisacodyl 5mg

Acacia, Anhydrous CalciumSulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalatic, Povidone, Shellac, Sodium Starch Glycolate,Stearic Acid, Sugar, Talc, Titanium Dioxide

Stimulant Laxative

Keep out of Reach of Children:  In case of overdose, get medical help or contact a Poison Control Center right away.

Temporarily reliefves occasional constipation and irregularity

Warning:  Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have:  stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.

When using this product:  Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomack discomfort, faintness or cramps.

adults and children 12 years and over: take 1 to 3 tablets (usually 2A) daily, or as directed by a doctor
children 6 to under 12 years: take 1 tablet daily, or as directed by a doctor
children under 6 yearts: ask a doctor

STIMULANT LAXATIVE 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYVINYL ACETATE PHTHALATE 
POVIDONE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint CodeTCL003
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-003-101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
2NDC:49483-003-01100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
3NDC:49483-003-5225 TABLET, DELAYED RELEASE in 1 BLISTER PACK
4NDC:49483-003-00100000 TABLET, DELAYED RELEASE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/01/2014
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC.037052099manufacture(49483-003)

 
TIME CAP LABORATORIES, INC.

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Medically reviewed on Jul 23, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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