Gentle and effective laxativeenteric coated tablet, coated

Ingredients and appearance - Product information

Gentle and effective laxativeenteric coated tablet, coated- Bisacodyl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 55312-190
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Bisacodyl ( UNII: 10X0709Y6I)( Deacetylbisacodyl - UNII: R09078E41Y ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
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)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Shellac ( UNII: 46N107B71O)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Stearic acid ( UNII: 4ELV7Z65AP)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyvinyl acetate phthalate ( UNII: 58QVG85GW3)
Povidone ( UNII: FZ989GH94E)
Ferric oxide red ( UNII: 1K09F3G675)
Ferrosoferric oxide ( UNII: XM0M87F357)
Ferric oxide yellow ( UNII: EX438O2MRT)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Sucrose ( UNII: C151H8M554)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color ORANGE Imprint Code TCL003
Score 1 Shape ROUND
Size 6 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part334 USA

Labeler - Western Family Foods, Inc.( 192166072)