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 enteric coated tablet)

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative

Use

for temporary relief of occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours

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 pregnancy 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 at controlled room temperature 15º-30ºC (59º-86ºF)

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 (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in DULCOLAX®*

Gentle

LAXATIVE

BISACODYL USP 5 mg

Guaranteed relief
Gentle yet effective

Tablets

Enteric coated

EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

OVERNIGHT RELIEF

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Health Care Products, owner of the registered trademark Dulcolax®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com 1-800-shop-CVS

Product Label

BISACODYL USP 5 MG

CVS GENTLE LAXATIVE

BISACODY ENTERIC COATED
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:59779-990
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (BISACODYL)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA
CALCIUM SULFATE ANHYDROUS
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TALC
TITANIUM DIOXIDE
Polyvinyl Acetate Phthalate
SUCROSE
POVIDONES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 400
ALUMINUM OXIDE

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL003
Contains

#	Item Code	Package Description
Packaging
1	NDC:59779-990-03	1 in 1 CARTON
1		25 in 1 BLISTER PACK
2	NDC:59779-990-50	2 in 1 CARTON
2		25 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/10/2013

Labeler - CVS Pharmacy (062312574)

Registrant - P and L Development of New York Corporation (800014821)

Revised: 3/2013

Document Id: 89bdd670-8ed4-4cd8-8087-d6bd7c82cea6

Set id: 77d31b15-d691-476f-999e-a2ac6127201e

Version: 2

Effective Time: 20130306

CVS Pharmacy