BISACODYL tablet, delayed release

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each tablet)

Bisacodyl (USP) 5 mg
Purpose

Stimulant laxative
Uses
- 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
PREGNANCY OR BREAST FEEDING

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 1(800)222-1222

Directions

take with a glass of water


adults and children 12 years 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
- each tablet contains: magnesium 5 mg
- store at 20-25°C (68-77°F)
- 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 or comments?

1-888-333-9792
SPL UNCLASSIFIED SECTION

Distributed By

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL - 5 mg tablets bottle

VALUMEDS

Compare to the

active ingredient

in DULCOLAX®*

Laxative

BISACODYL USP 5 mg

Gentle

Overnight Relief

100 TABLETS

INGREDIENTS AND APPEARANCE

BISACODYL
bisacodyl tablet, delayed release

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)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68210-0312-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/19/2017

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Name	Address	ID/FEI	Business Operations
Establishment
TIME-CAP LABS, INC.		037052099	manufacture(68210-0312)

BISACODYL by