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NDC 00037-6321-90 URELLE .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 Details
URELLE .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1
URELLE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE.
Product Information
| NDC | 00037-6321 |
|---|---|
| Product ID | 0037-6321_3c4ac6f5-f382-4cf7-aa0d-87959fa0c705 |
| Associated GPIs | 16992005200320 |
| GCN Sequence Number | 050518 |
| GCN Sequence Number Description | meth/meblue/sod phos/psal/hyos TABLET 81-0.12MG ORAL |
| HIC3 | W2G |
| HIC3 Description | ANTIBIOTIC, ANTIBACTERIAL, MISC. |
| GCN | 17603 |
| HICL Sequence Number | 034934 |
| HICL Sequence Number Description | METHENAMINE/METHYLENE BLUE/SOD PHOS/P.SALICYLATE/HYOSCYAMINE |
| Brand/Generic | Brand |
| Proprietary Name | URELLE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | .12; 81; 10.8; 32.4; 40.8 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1; mg/1 |
| Substance Name | HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
| Labeler Name | Meda Pharmaceuticals |
| Pharmaceutical Class | Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00037-6321-90 (00037632190)
| NDC Package Code | 0037-6321-90 |
|---|---|
| Billing NDC | 00037632190 |
| Package | 90 TABLET in 1 BOTTLE (0037-6321-90) |
| Marketing Start Date | 2015-01-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1d80a11c-6f86-403b-85d4-32ec1924dbe9 Details
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.
INDICATIONS and USAGE:
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:
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.
SPL UNCLASSIFIED SECTION
DOSAGE and ADMINISTRATION:
HOW SUPPLIED:
SPL UNCLASSIFIED SECTION
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
INGREDIENTS AND APPEARANCE
| URELLE
hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate tablet |
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| Labeler - Meda Pharmaceuticals (051229602) |