BISACODYL  - bisacodyl tablet, delayed release 
Sunrise Pharmaceutical Inc

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Bisacodyl USP 5 mg Laxative

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

1bb6872e-figure-01

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: 06/2010 Sunrise Pharmaceutical Inc