THE MEDICINE SHOPPE GENTLE LAXATIVE- bisacodyl tablet 
The Medicine Shoppe International

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.

----------

The Medicine Shoppe Gentle Laxative

Active ingredient(s)

Bisacodyl USP 5 mg

Purpose

Stimulant Laxative

Use(s)

Warnings

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 2 weeks

  When using this product 

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness or cramps
  • do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product.  These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.


Directions

take with a glass of water

adults and children 12 years and over take 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age take 1 tablet in a single daily dose
 children under 6 years of age ask a doctor

Other information

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.


Principal Display Panel

The Medicine Shoppe

Gentle Laxative

Overnight Relief of Constipation and Irregularity

*Compare to the active ingredient of Dulcolax®

LAXATIVE

Bisacodyl USP, 5 mg

25 Coated Tablets

 

CIN 1796986

Distributed By:

The Medicine Shoppe International, Inc.

Earth City MO 63045

www.medicineshoppe.com

A Cardinal Health Company

Questions? 1-800-325-1397

Medicine Shoppe Gentle Laxative 25ct
THE MEDICINE SHOPPE GENTLE LAXATIVE 
bisacodyl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49614-131
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TCL;003
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49614-131-63 1 in 1 CARTON
1 25 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 10/14/2011
Labeler - The Medicine Shoppe International (071997654)

Revised: 2/2012
Document Id: 22cdf899-52f4-417f-93e4-a42881bd11cf
Set id: 22cdf899-52f4-417f-93e4-a42881bd11cf
Version: 1
Effective Time: 20120201
 
The Medicine Shoppe International