NDC Code(s) : 68016-688-10, 68016-688-25
Packager : Chain Drug Consortium

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BisacodylBisacodyl TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-688
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL(UNII: 10X0709Y6I)
(DEACETYLBISACODYL - UNII:R09078E41Y) 		BISACODYL5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
AMMONIA(UNII: 5138Q19F1X)
CALCIUM CARBONATE(UNII: H0G9379FGK)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6 ALUMINUM LAKE(UNII: GYP6Z2JR6Q)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Polyvinyl Acetate Phthalate(UNII: 58QVG85GW3)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SHELLAC(UNII: 46N107B71O)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color orange Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68016-688-101 in 1 CARTON 25/03/2002
1100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:68016-688-251 in 1 CARTON 25/03/2002
225 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 03/25/2002

LABELER - Chain Drug Consortium(101668460)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 manufacture(68016-688), pack(68016-688)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(68016-688), pack(68016-688)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(68016-688)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(68016-688)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(68016-688)

PRINCIPAL DISPLAY PANEL

Premier
Value®

*COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® LAXATIVE TABLETS

Bisacodyl, 5 mg
Bisacodyl USP, 5 mg

STIMULANT LAXATIVE

Gentle, dependable
constipation relief

Comfort coated

100 Tablets

actual size

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.
50844       REV0119A32712

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Premier Value 44-327Premier Value 44-327