Label: URELLE- hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate tablet

  • NDC Code(s): 66663-219-01
  • Packager: Jazz Pharmaceuticals Commercial Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 7, 2012

If you are a consumer or patient please visit this version.

  • 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

    Close
  • 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.

    Close
  • 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.

    Close
  • 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).

    Close
  • 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.

    Close
  • 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® 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 a patient receiving a 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 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 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 a 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 a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue.

    Report adverse events involving methylene blue to the FDA MedWatch program by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For more information on Urelle®, call 877 329 2256.

    Close
  • 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.

    Close
  • How Supplied:

    Urelle® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 66663-219-01).

    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.

    Distributed by: JAZZ PHARMACEUTICALS COMMERCIAL CORP. • Philadelphia, PA 19103 • www.jazzpharma.com

    Manufactured by: PureTek Corporation. San Fernando, CA 91340

    Urelle® is a registered trademark of Jazz Pharmaceuticals.

    To report a serious adverse event or obtain product information, contact (800) 890 3098.

    Rx Only

    URLLw-12-01

    Close
  • PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    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 please refer to www.jazzpharma.com.

    To report a serious adverse event or obtain product
    information, contact (800) 890 3098.

    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.

    90 TABLETS                     NDC 66663-219-01

    urelle®

    Urinary Antiseptic

    Rx Only

    Dist. by: JAZZ PHARMACEUTICALS COMMERCIAL CORP.
    Philadelphia, PA 19103

    Mfd. by: PureTek Corporation
    San Fernando, CA 91340

    Urelle® is a registered trademark of Jazz Pharmaceuticals.

    Note: Patients should be advised
    that urine will be colored blue when
    taking this medication.

    URLLt-12-02

    Principal Display Panel - Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    URELLE 
    hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66663-219
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE 0.12 mg
    METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE 81 mg
    METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE - UNII:T42P99266K) METHYLENE BLUE 10.8 mg
    PHENYL SALICYLATE (UNII: 28A37T47QO) (PHENYL SALICYLATE - UNII:28A37T47QO) PHENYL SALICYLATE 32.4 mg
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE (Navy) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code A002
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66663-219-01 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2002
    Labeler - Jazz Pharmaceuticals Commercial Corp. (805611071)
    Close