BISACODYL- bisacodyl tablet, coated
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Bisacodyl Enteric Coated Tablet

Active ingredient(s)

Drug Facts

Active Ingredient (in each tablet)

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 over 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

-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. These may be signs of a serious condition.

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

Pregnancy/Breastfeeding

If pregnant or breast-feeding ask a doctor before use.

Keep out of reach of children

This package is intended for institutional use only., Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over- take 1 to 3 tablets (usually 2) in a single daily dose

children 6 to under 12 years - take 1 tablet daily

children under 6 years - ask a doctor

Other information

Storage -Store at 20-25 C (68-77 F) excursions permitted between 15-30 C (59-86 F)

[See USP Controlled Rrom Temperature].

-Avoid excessive humidity

Inactive ingredients

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

Generic Section

Distributed by

MAJOR PHARMACEUTIALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By LNK, Hauppauge, NY 11788

Questions

Questions or Comments? (800) 616-2471

MAJOR is a trademark owned by its respective owner.

Repackaged by Cardinal Health

Zanesville, OH 43701

L3511797-10314

Principal Display Panel

Bisacodyl Enteric Coated Tabs, USP 5mg

Enteric Coated Tablets

Delayed Release

10 Tablets

BISACODYL
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-0674(NDC:0904-7927)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
APIS MELLIFERA (UNII: 7S82P3R43Z)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SHELLAC (UNII: 46N107B71O)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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	5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-0674-0	10 in 1 BAG	06/02/2011	01/31/2016
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/02/2011	01/31/2016

Labeler - Cardinal Health (188557102)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-0674)

Revised: 5/2017

Document Id: f74c67ec-3181-4466-ac3f-4c6c973fa89f

Set id: 0e55f510-8c43-4b3a-a6d3-c44d8169cb37

Version: 6

Effective Time: 20170530

Cardinal Health