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URELLE

Generic: hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate

Verified·Apr 23, 2026
Manufacturer
Damon Industries
NDC
0037-6321
RxCUI
1048336
Route
ORAL
ICD-10 indication
N39.0

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About URELLE

What is this medication? Urelle is a prescription combination medication specifically formulated to provide relief from symptoms associated with lower urinary tract irritation. It contains several active ingredients, including methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, and hyoscyamine sulfate. These components work together to reduce pain, decrease urinary urgency, and manage bladder spasms that often occur during a urinary tract infection or following certain diagnostic procedures. In addition to its analgesic and antispasmodic properties, the medication acts as a mild urinary antiseptic to help inhibit the growth of bacteria in the urine. It is important to note that Urelle is primarily used for symptom management and is not typically a substitute for standard antibiotic treatment if a bacterial infection is present. Patients taking this medication should be aware that it may cause the urine or stool to turn a blue or green color, which is a harmless side effect of the methylene blue component.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for URELLE. Official source: DailyMed (NLM) · Label effective Jan 13, 2015

Indications and usage
INDICATIONS and USAGE: Urelle ® 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.
Dosage and administration
DOSAGE and ADMINISTRATION: Adults – One tablet orally 4 times per day followed by liberal fluid intake. Pediatric – Dosage must be individualized by a physician for older children. Urelle® is not recommended for use in children 6 years of age or younger.
Contraindications
CONTRAINDICATIONS: Hypersensitivity to any of the ingredients is possible. Risk - benefit should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).
Warnings
WARNINGS: If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately. Patients should be advised that urine will be colored blue when taking this medication. Do not exceed recommended dosage.
Adverse reactions
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Prior authorization & coverage

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.