BISACODYL- biscodyl tablet, coated

BISACODYL by

Drug Labeling and Warnings

BISACODYL by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES, INC, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

In each tablet: Bisacodyl 5mg

INACTIVE INGREDIENT

Acacia, Anhydrous CalciumSulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch,

D&C Yellow #10 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre),

FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400,

Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

PURPOSE

PURPOSE

Stimulant Laxative

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses:

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

WARNINGS

WARNINGS

Warning: 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 two weeks.

When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

DOSAGE & ADMINISTRATION

adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
children 6 to under 12 years: take 1 tablet in a single daily dose
children under 6 years: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISACODYL 
biscodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-182
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 SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE (UNII: FZ989GH94E)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	TCL003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-182-52	25 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/04/2020

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(11673-182)