UNIT DOSE BISACODYL- bisacodyl tablet, coated

Unit Dose Bisacodyl by

Drug Labeling and Warnings

Unit Dose Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 107, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl 5 mg

Enteric Coated Tablets

Purpose

Stimulant laxative

Uses

• relieves occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 12 hours

Warnings

This Unit Dose package is not child resistant and is Intended for Institutional Use Only. 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 (1-800-222-1222) right away.

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)
• do not use within 1 hour after taking an antacid or milk
• you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

• have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
• you need to use a laxative for more than 1 week

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• avoid excessive humidity

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

(800) 616-2471

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L5071915-10218

L5071915-20218

Principal Display Panel

Bisacodyl 5 mg

Enteric Coated Tablets

10 Tablets

INGREDIENTS AND APPEARANCE

UNIT DOSE BISACODYL 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-6897(NDC:0904-6407)
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 CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: 55154-6897-0	10 in 1 BAG	03/25/2002
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/25/2002

Labeler - Cardinal Health (603638201)