Bisacodyl USP 5 mg Laxative

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 over1 to 3 tablets in a single daily dose
Children 6 to under 12 years1 tablet in a single daily dose
Children under 6 yearsAsk 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 TypeHUMAN OTC DRUGNDC Product Code (Source)11534-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore no score
ShapeROUNDSize6mm
FlavorImprint Code S1
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
111534-013-2525 TABLET In 1 BOTTLENone
211534-013-01100 TABLET In 1 BOTTLENone
311534-013-031000 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/08/2005

Labeler - Sunrise Pharmaceutical Inc (168522378)
Revised: 06/2010Sunrise Pharmaceutical Inc