NDC Code(s) : 49483-046-00, 49483-046-51
Packager : Time-Cap Labs, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NEW CORRECT BISACODYL TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-046
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL(UNII: 10X0709Y6I)
(BISACODYL - UNII:10X0709Y6I) 		BISACODYL5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS(UNII: E934B3V59H)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 7(UNII: ECW0LZ41X8)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
FERROUS OXIDE (UNII: G7036X8B5H)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
KAOLIN(UNII: 24H4NWX5CO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
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)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code TCL057
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49483-046-00100000 in 1 CARTON
2NDC:49483-046-5115 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 08/06/2008

PRINCIPAL DISPLAY PANEL

BISACODYL D-R TABLETS 5 MG246RBULK LABEL