INFORMATION FOR PATIENTS SECTION.

Drug Interactions:. Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A-- an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Urelle(R) tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 0037-6321-90). Store at controlled room temperature 20-25C (68-77F).Dispense in tight, light resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

INDICATIONS & USAGE SECTION.

INDICATIONS and USAGE:. Urelle(R) 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.

ADVERSE REACTIONS SECTION.

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.

CONTRAINDICATIONS SECTION.

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).

DESCRIPTION SECTION.

DESCRIPTION:. Urelle(R) 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 mgINACTIVE INGREDIENTS:Corn Starch, Dicalcium Phosphate, FD&C Blue 2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE and ADMINISTRATION:. Adults One tablet orally times per day followed by liberal fluid intake. Pediatric Dosage must be individualized by physician for older children. Urelle(R) is not recommended for use in children years of age or younger.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL BOTTLE LABEL. NDC 0037-6321-9090 TABLETSUrelle(R) Urinary AntisepticRx onlyDistributed by: MEDAPHARMACEUTICALS(R) Somerset, New Jersey 08873-4120(C) 2018 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS(R) and URELLE(R) are registered trademarks of Meda AB or related entity.Description: Urelle(R) tablets for oral administration are supplied as navy blueround tablets with A-002 debossed on one side.Each Tablet Contains: Hyoscyamine Sulfate 0.12 mgMethenamine 81.0 mgMethylene Blue 10.8 mgPhenyl Salicylate 32.4 mgSodium Phosphate Monobasic 40.8 mgDosage: Adults one tablet orally times per day followed by liberal fluid intake.Pediatric Dosage must be individualized by physician for older children.Urelle(R) is not recommended for use in children years of age or younger.Precaution: Contains Methylene Blue and should NOT be taken with serotonergicpsychiatric medications. For full product information see package insert.To report SUSPECTED ADVERSE REACTIONS, contact Meda PharmaceuticalsInc. at 1-877-999-8402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Storage: Store at controlled room temperature 20-25C (68-77F). Dispensein 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 takingthis medication.LB-632110-02 Rev. 02/2018. Urelle Antiseptic Label.

PRECAUTIONS SECTION.

PRECAUTIONS:. Cross sensitivity and/or related problems patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.Urelle(R) contains methylene blue. Methylene blue should generally NOT be given to patients taking serotonergic drugs.. Drug Interactions:. Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A-- an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.. Additional Information for Healthcare Professionals: Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity.In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity. If methylene blue must be administered to patient receiving serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first.In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate. Most serotonergic psychiatric drugs should be stopped at least weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has longer half-life compared to similar drugs, should be stopped at least weeks in advance.Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue.Serotonergic psychiatric medications should not be started in patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant.Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.

SPL UNCLASSIFIED SECTION.

Distributed by: Meda Pharmaceuticals(R) Somerset, New Jersey 08873-4120(C) 2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and URELLE are registered trademarks of Meda AB or related entity.Rx OnlyIN-632110-01Rev. 07/2014.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

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.