UROGESIC BLUE (Page 2 of 2)

CAUTION

Rx ONLY

STORAGE

Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured for:
Edwards Pharmaceutical, Inc. 111 W. Mulberry St. Ripley, Mississippi 38663

Manufactured by:
Belcher Pharmaceuticals, LLC. Largo, FL 33777

November 2014 R-1410

PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label

FORMULATION

UROGESIC-BLUE™

URINARY ANTISEPTIC ANTISPASMODIC

DESCRIPTION: Each tablet contains:
Methenamine, USP 81.6 mg
Monobasic Sodium Phosphate, USP 40.8 mg
Methylene Blue, USP 10.8 mg
Hyoscyamine Sulfate, USP 0.12 mg

CONTENTS: 30 TABLETS

Rx ONLY

Manufactured for
EDWARDS PHARMACEUTICAL, INC.

Berwyn, PA

label
(click image for full-size original)
UROGESIC BLUE
methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0485-0151
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg
SODIUM PHOSPHATE, MONOBASIC (SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC 40.8 mg
METHYLENE BLUE (METHYLENE BLUE CATION) METHYLENE BLUE 10.8 mg
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
MANNITOL
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color blue (LIGHT BLUE) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code ED;UB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0485-0151-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/19/2010
Labeler — EDWARDS PHARMACEUTICALS, INC. (195118880)
Establishment
Name Address ID/FEI Operations
Belcher Pharmaceuticals, LLC 965167955 manufacture (0485-0151), analysis (0485-0151), pack (0485-0151)

Revised: 01/2023 EDWARDS PHARMACEUTICALS, INC.

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