BISACODYL tablet, delayed release

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Sunrise Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Bisacodyl USP 5mg.

PURPOSE

Stimulant laxative.

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Dosage and Administration text

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

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl tablet, delayed release

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE (UNII: WAT0DDB505)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
KAOLIN (UNII: 24H4NWX5CO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11534-013-25	25 in 1 BOTTLE
2	NDC: 11534-013-01	100 in 1 BOTTLE
3	NDC: 11534-013-03	1000 in 1 BOTTLE

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)