Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate

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

Over-the-Counter (OTC)

Brand Names:

Urelle

DESCRIPTION: Urelle ® tablets for oral administration are supplied as navy blue round tablets with “A-002” debossed on one side. Each Tablet Contains: Hyoscyamine Sulfate 0.12 mg Methenamine 81.0 mg Methylene Blue 10.8 mg Phenyl Salicylate 32.4 mg Sodium Phosphate Monobasic 40.8 mg INACTIVE INGREDIENTS: Corn Starch, Dicalcium Phosphate, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.

Overview

DESCRIPTION: Urelle ® tablets for oral administration are supplied as navy blue round tablets with “A-002” debossed on one side. Each Tablet Contains: Hyoscyamine Sulfate 0.12 mg Methenamine 81.0 mg Methylene Blue 10.8 mg Phenyl Salicylate 32.4 mg Sodium Phosphate Monobasic 40.8 mg INACTIVE INGREDIENTS: Corn Starch, Dicalcium Phosphate, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.

Uses

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

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.

Side Effects

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.

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. 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...

Storage

Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in a tight, light resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Frequently Asked Questions

What is Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate used for?

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.

What are the side effects of Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate?

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.

What are the important warnings for Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate?

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. 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...

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.