NDC Code(s) : 51862-175-01
Packager : Mayne Pharma Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

UR N-C Urinary AntisepticHyoscyamine Sulfate, Methenamine, Phenyl Salicylate, Sodium Phosphate Monobasic, Methylene Blue TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE(UNII: F2R8V82B84)
(HYOSCYAMINE - UNII:PX44XO846X) 		HYOSCYAMINE SULFATE0.12 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
(SODIUM CATION - UNII:LYR4M0NH37) 		SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE40.8 mg
PHENYL SALICYLATE(UNII: 28A37T47QO)
(PHENYL SALICYLATE - UNII:28A37T47QO) 		PHENYL SALICYLATE36.2 mg
METHENAMINE(UNII: J50OIX95QV)
(METHENAMINE - UNII:J50OIX95QV) 		METHENAMINE81.6 mg
METHYLENE BLUE(UNII: T42P99266K)
(METHYLENE BLUE CATION - UNII:ZMZ79891ZH) 		METHYLENE BLUE10.8 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE, UNSPECIFIED FORM(UNII: WAT0DDB505)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: HHT01ZNK31)
D&C RED NO. 27(UNII: 2LRS185U6K)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
WATER(UNII: 059QF0KO0R)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code 293
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51862-175-01100 in 1 BOTTLE Type 0: Not a Combination Product21/05/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011 04/30/2018

PRINCIPAL DISPLAY PANEL

NDC 51862-175-01

UR N-C

Urinary Antiseptic

Each tablet for oral administration contains:

Hyoscyamine sulfate……...12 mg

Methenamine.....81.6 mg

Methylene blue.....10.8 mg

Phenyl salicylate.....36.2 mg

Sodium phosphate monobasic…..40.8 mg

Rx Only

100 TABLETS

Libertas
Pharma, Inc.

Container Label