Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Urelle ® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 0037-6321-90). 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.; PRINCIPAL DISPLAY PANEL – BOTTLE LABEL NDC 0037-6321-90 90 TABLETS Urelle ® Urinary Antiseptic Rx only Distributed by: MEDA PHARMACEUTICALS ® Somerset, New Jersey 08873-4120 © 2018 Meda Pharmaceuticals Inc. MEDA PHARMACEUTICALS® and URELLE® are registered trademarks of Meda AB or a related entity. 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 Dosage: 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. Precaution: Contains Methylene Blue and should NOT be taken with serotonergic psychiatric medications. For full product information see package insert. 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. 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 OUT OF THE REACH OF CHILDREN. Note: Patients should be advised that urine will be colored blue when taking this medication. LB-632110-02 Rev. 02/2018 Urelle Antiseptic Label
- HOW SUPPLIED: Urelle ® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 0037-6321-90). 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.
- PRINCIPAL DISPLAY PANEL – BOTTLE LABEL NDC 0037-6321-90 90 TABLETS Urelle ® Urinary Antiseptic Rx only Distributed by: MEDA PHARMACEUTICALS ® Somerset, New Jersey 08873-4120 © 2018 Meda Pharmaceuticals Inc. MEDA PHARMACEUTICALS® and URELLE® are registered trademarks of Meda AB or a related entity. 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 Dosage: 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. Precaution: Contains Methylene Blue and should NOT be taken with serotonergic psychiatric medications. For full product information see package insert. 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. 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 OUT OF THE REACH OF CHILDREN. Note: Patients should be advised that urine will be colored blue when taking this medication. LB-632110-02 Rev. 02/2018 Urelle Antiseptic Label
Overview
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.
Indications & 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 & 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.
Warnings & Precautions
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 obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).
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.
Storage & Handling
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.
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