BISACODY ENTERIC COATED- bisacodyl tablet, coated 
CVS Pharmacy

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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Drug Facts

Active ingredient (in each tablet)

 Bisacodyl USP 5 mg

Purpose

 Stimulant laxative

Use

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)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps

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 of age 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

• store between 20º-25ºC (68º-77ºF)

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

Questions or comments?

Call  1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in DULCOLAX®*

Gentle

LAXATIVE

BISACODYL,  5 mg

Tablets

Enteric coated

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., distributor of Dulcolax® Laxative.

Distributed by:  CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI  02895

CVS.COM® 1-800-SHOP CVS

Product Label

 Bisacodyl 5mg

CVS Enteric Coated LaxativeTablets

BISACODY  ENTERIC COATED
bisacodyl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-990
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
SUCROSE (UNII: C151H8M554)  
POVIDONES (UNII: FZ989GH94E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TCL003
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-990-50 2 in 1 CARTON
1 25 in 1 BLISTER PACK
2 NDC:59779-990-10 10 in 1 CARTON
2 1 in 1 BLISTER PACK
3 NDC:59779-990-25 25 in 1 CARTON
3 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 01/10/2013
Labeler - CVS Pharmacy (062312574)

Revised: 5/2014
Document Id: ff03992a-4a49-4361-a481-fd0f5184c425
Set id: 77d31b15-d691-476f-999e-a2ac6127201e
Version: 3
Effective Time: 20140512
 
CVS Pharmacy