BISACODYL tablet, coated

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, TIME CAP LABORATORIES INC, TIME CAP LABS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredeint (in each tablet)

Bisacodyl 5 mg

INACTIVE INGREDIENT

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

PURPOSE

Stimulant Laxative

INDICATIONS & USAGE

Uses:

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

DOSAGE & ADMINISTRATION

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

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-003
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
POVIDONE (UNII: FZ989GH94E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SUCROSE (UNII: C151H8M554)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STARCH, CORN (UNII: O8232NY3SJ)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ACACIA (UNII: 5C5403N26O)
TALC (UNII: 7SEV7J4R1U)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 41226-003-52	25 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/01/2020

Labeler - KROGER COMPANY (006999528)

Registrant - TIME CAP LABORATORIES INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS		037052099	manufacture(41226-003)