BISACODYL ENTERIC COATED- bisacodyl tablet, coated

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

 Bisacodyl 5mg

Purpose

 Stimulant laxative

Use(s)

 -relieves occasional constipation and irregularity

 -this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

 Do not use if you cannot swallow without chewing

Ask a doctor before use if

 -you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

When using this product

 -do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

 -you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

 ask a health professions before use.

Keep out of reach of children

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- 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 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity

Storage

Inactive ingredients

acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

Questions

 To Report Adverse Drug Event call: (800) 616-2471

HOW SUPPLIED

Product: 71335-0084

NDC: 71335-0084-1 30 TABLET, COATED in a BOTTLE

NDC: 71335-0084-2 2 TABLET, COATED in a BOTTLE

NDC: 71335-0084-3 3 TABLET, COATED in a BOTTLE

NDC: 71335-0084-4 4 TABLET, COATED in a BOTTLE

NDC: 71335-0084-5 10 TABLET, COATED in a BOTTLE

NDC: 71335-0084-6 90 TABLET, COATED in a BOTTLE

NDC: 71335-0084-7 8 TABLET, COATED in a BOTTLE

NDC: 71335-0084-8 100 TABLET, COATED in a BOTTLE

NDC: 71335-0084-9 20 TABLET, COATED in a BOTTLE

Bisacodyl 5mg Tablet

INGREDIENTS AND APPEARANCE

BISACODYL  ENTERIC COATED
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0084(NDC:0904-7927)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0084-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
2	NDC: 71335-0084-2	2 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
3	NDC: 71335-0084-8	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
4	NDC: 71335-0084-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
5	NDC: 71335-0084-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
6	NDC: 71335-0084-3	3 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
7	NDC: 71335-0084-4	4 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
8	NDC: 71335-0084-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008
9	NDC: 71335-0084-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/24/2008

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0084) , RELABEL(71335-0084)