UR N-C Urinary Antiseptic

Name: UR N-C Urinary Antiseptic

Indications and usage

UR N-C is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Contraindications

UR N-C is contraindicated in patients hypersensitive to any of its ingredients. Risk benefits should be carefully considered when the following medical problems exist: achalasia of esophagus, atony of colon, diseases of cardiovascular system, gastrointestinal hemorrhage; glaucoma; hemolytic anemia from pyruvate kinase and G6PD deficiencies, infected urolithiasis, myasthenia gravis, paralytic ileus, severe ulcerative colitis, toxic megacolon; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Adverse reactions

Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficulty micturition, acute urinary retention Gastrointestinal: dry mouth, nausea and vomiting Respiratory: shortness of breath or trouble breathing

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. The following number does not provide medical advice, but in the U.S. you may report suspected side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug interactions

This drug should not be used with the following medications because very serious interactions may occur: live influenza virus vaccine, pramlintide. Because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine sulfate because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine sulfate, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine sulfate; antimyasthenics (concurrent use with hyoscyamine sulfate may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). This is not a complete list of all drug interactions. Tell your doctor or pharmacist of all prescription medications prior to use.

Container Label

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.

UR N-C Urinary Antiseptic 
hyoscyamine sulfate, methenamine, phenyl salicylate, sodium phosphate monobasic, methylene blue tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51862-175
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg
PHENYL SALICYLATE (PHENYL SALICYLATE) PHENYL SALICYLATE 36.2 mg
METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg
METHYLENE BLUE (METHYLENE BLUE CATION) METHYLENE BLUE 10.8 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE, UNSPECIFIED FORM  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
D&C RED NO. 27  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
POLYVINYL ALCOHOL, UNSPECIFIED  
WATER  
STARCH, CORN  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 293
Contains     
Packaging
# Item Code Package Description
1 NDC:51862-175-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011 04/30/2018
Labeler - Mayne Pharma Inc. (867220261)
Revised: 08/2016   Mayne Pharma Inc.
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