STIMULANT LAXATIVE- bisacodyl tablet, delayed release

STIMULANT LAXATIVE by

Drug Labeling and Warnings

STIMULANT LAXATIVE by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, 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), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalatic, Povidone, Shellac, Sodium Starch Glycolate,Stearic Acid, Sugar, Talc, Titanium Dioxide

PURPOSE

Stimulant Laxative

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

Temporarily reliefves occasional constipation and irregularity

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 stomack discomfort, faintness or cramps.

DOSAGE & ADMINISTRATION

adults and children 12 years and over: take 1 to 3 tablets (usually 2A) daily, or as directed by a doctor
children 6 to under 12 years: take 1 tablet daily, or as directed by a doctor
children under 6 yearts: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0228
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)
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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
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: 70000-0228-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/24/2017

Labeler - CARDINAL HEALTH (097537435)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(70000-0228)