BISACODYL tablet, delayed release

Bisacodyl by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl 5 mg

PURPOSE

Stimulant laxative

INDICATIONS & 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 a doctor before use if you have

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts 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 a serious condition.
• You need to use a 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 of age and over: 1 to 3 tablets in a single daily dose
• children 6 to under 12 years of age: 1 tablet in a single daily dose
• children under 6 years of age: ask a doctor

Other information

• Store at 20 - 250C (68-770F)
  
• Protect from excessive humidity

Inactive ingredients: acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 lake, edible ink, FD&C yellow #6 lake, gelatin, iron oxide black, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sugar, titanium dioxide

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-367
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
ACACIA (UNII: 5C5403N26O)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALCIUM SULFATE (UNII: WAT0DDB505)
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 (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 16103-367-17	25 in 1 BOTTLE, PLASTIC
2	NDC: 16103-367-08	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/25/2006

Labeler - Pharbest Pharmaceuticals Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals Inc.		557054835	repack, relabel