BISACODYL- bisacodyl tablet, coated
The Kroger Co.

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 and 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. (1-800-222-1222)

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?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of DULCOLAX® *See side panel

Laxative Tablets

Bisacodyl, USP 5 mg

STIMULANT LAXATIVE

Gentle, Predictable Overnight Relief From Constipation

ENTERIC COATED TABLETS

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.

*Dulcolax® is a registered trademark of Boehringer Ingelheim Corporation, Plainsboro, NJ 08536. Boehringer Ingelheim Corporation is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

Product Label

Kroger Laxative Tablets

BISACODYL
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:30142-191
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
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
Polyvinyl Acetate Phthalate
POVIDONES
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE
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:30142-191-03	1 in 1 CARTON
1		25 in 1 BLISTER PACK
2	NDC:30142-191-01	4 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	12/30/2013

Labeler - The Kroger Co. (006999528)

Revised: 1/2014

Document Id: f4b9c187-c16d-491c-aa2e-4982ac08e923

Set id: 667af712-84fc-410d-854f-b489dd9054d7

Version: 1

Effective Time: 20140113

The Kroger Co.