ACTIVE INGREDIENT

Bisacodyl USP 5mg.

PURPOSE

Stimulant laxative.

USE

For temporary relief of occasional constipation and irregularity

This product generally produces bowel movement in 6 to 12 hours.

WARNINGS

Do not use if you cannot swallow without chewing.

ASK DOCTOR BEFORE USE IF YOU HAVE

Stomach pain, nausea or vomiting

A sudden change in bowel habits that lasts for 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 serious condition.

You need to use 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	1 to 3 tablets in a single daily dose
Children 6 to under 12 years	1 tablet in a single daily dose
Children under 6 years	Ask a doctor

OTHER INFORMATION

Store at 20°-25°C(68°-77°F)

INACTIVE INGREDIENT

Calcium sulfate, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, edible ink, FD & C yellow #6, gelatin, hydroxypropylymethyl cellulose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline celloluse, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BISACODYL
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	11534-013
Route of Administration	ORAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSE
KAOLIN
LACTOSE
MAGNESIUM STEARATE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	S1
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11534-013-25	25 TABLET In 1 BOTTLE	None
2	11534-013-01	100 TABLET In 1 BOTTLE	None
3	11534-013-03	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/08/2005

Labeler - Sunrise Pharmaceutical Inc (168522378)

Revised: 06/2010Sunrise Pharmaceutical Inc