BISACODYL- bisacodyl enteric coated tablet, coated
NCS HealthCare of KY, LLC dba Vangard Labs

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.

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Bisacodyl Enteric Coated Tablet

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

If pregnant or breastfeeding

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

-use by expiration date on package

-protect from excessive humidity

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

Questions

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

Principal Display Panel

Bisacodyl Enteric Coated Tabs, USP 5mg

BISACODYL
bisacodyl enteric coated tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-0598(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)
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 (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCROSE (UNII: C151H8M554)
YELLOW WAX (UNII: 2ZA36H0S2V)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POVIDONE (UNII: FZ989GH94E)

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:0615-0598-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/08/2010	02/28/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/02/1993	02/28/2018

Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-0598)

Revised: 10/2022

Document Id: 719782b0-83b5-44f2-ae68-5073cb5b5307

Set id: 6d2f1549-a692-4a37-b13f-64f858232967

Version: 9

Effective Time: 20221031

NCS HealthCare of KY, LLC dba Vangard Labs