Urelle
Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate
Meda Pharmaceuticals
Human Prescription Drug
NDC 0037-6321Urelle also known as Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate is a human prescription drug labeled by 'Meda Pharmaceuticals'. National Drug Code (NDC) number for Urelle is 0037-6321. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Urelle drug includes Hyoscyamine Sulfate - .12 mg/1 Methenamine - 81 mg/1 Methylene Blue - 10.8 mg/1 Phenyl Salicylate - 32.4 mg/1 Sodium Phosphate, Monobasic, Monohydrate - 40.8 mg/1 . The currest status of Urelle drug is Active.
Drug Information:
| Drug NDC: | 0037-6321 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Urelle |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Meda Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYOSCYAMINE SULFATE - .12 mg/1
METHENAMINE - 81 mg/1
METHYLENE BLUE - 10.8 mg/1
PHENYL SALICYLATE - 32.4 mg/1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - 40.8 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 12 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Meda Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1048336
1048340
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | F2R8V82B84
J50OIX95QV
T42P99266K
28A37T47QO
593YOG76RN
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Oxidation-Reduction Activity [MoA]
Oxidation-Reduction Agent [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0037-6321-90 | 90 TABLET in 1 BOTTLE (0037-6321-90) | 12 Jan, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Urelle hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate hyoscyamine sulfate hyoscyamine methenamine methenamine methylene blue methylene blue cation phenyl salicylate phenyl salicylate sodium phosphate, monobasic, monohydrate phosphate ion starch, corn anhydrous dibasic calcium phosphate fd&c blue no. 2 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified talc titanium dioxide a002
Indications and Usage:
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.
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.
Dosage and Administration:
Dosage and administration: adults â one tablet orally 4 times per day followed by liberal fluid intake. pediatric â dosage must be individualized by a physician for older children. urelle® is not recommended for use in children 6 years of age or younger.
Contraindications:
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.
Description:
Description: urelle ® tablets for oral administration are supplied as navy blue round tablets with âa-002â 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.
How Supplied:
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.
Information for Patients:
Drug interactions: although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase aâ 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 dissipa
Read more...te. 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.
Package Label Principal Display Panel:
Principal display panel â 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 âa-002â 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