Uro-MP Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate 118 mg; 40.8 mg; 36 mg; 10 mg; .12 mg Capsule, 100-count — NDC 58657-0456-01 package photo

Uro-MP Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate 118 mg; 40.8 mg; 36 mg; 10 mg; .12 mg Capsule, 100-count

by Method Pharmaceuticals, LLC · 100 CAPSULE in 1 BOTTLE (58657-456-01)
NDC 58657-0456-01
🏷️ FDA NDC (as labeled) 58657-456-01 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 58657-456-01
Product NDC 58657-456
11-digit billing NDC 58657045601
NCPDP billing unit EA — each (per item)
RxCUI 1087365
UNII J50OIX95QV, KH7I04HPUU, 28A37T47QO, T42P99266K, F2R8V82B84
SPL Set ID 1e1b0dee-1a3b-4846-a212-c9febb3fc17d
Established class (EPC) Osmotic Laxative; Oxidation-Reduction Agent
Mechanism of action Osmotic Activity; Oxidation-Reduction Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-12-01
Route ORAL
Dosage form CAPSULE
Substance METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
GPI-14 16992005200128
GPI class Uro-MP
GCN Seq No 066391
GCN 28648
HICL code 034934
Ingredient (HICL) Meth/Meblue/Sod Phos/Psal/Hyos
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name URO-MP CAPSULE
FDB brand name Uro-Mp
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 58657-456-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58657-0456-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Belladonna alkaloids, tertiary amines class.

Drug family (ATC) Belladonna alkaloids, tertiary amines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMethod Pharmaceuticals, LLC
Labeler code58657
First marketedDec 2014
Product typeHuman Prescription Drug
Portfolio78 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name URO-MP CAPSULE Ingredient Meth/Meblue/Sod Phos/Psal/Hyos
🧪 What is this product?

Uro-MP is an oral capsule containing five active ingredients typically used together in urinary tract products. Methenamine and methylene blue are commonly included in formulations intended to support urinary tract health, while phenyl salicylate and sodium phosphate are additives often found in such preparations. Hyoscyamine sulfate is an anticholinergic ingredient typically used to help reduce urinary tract discomfort. This product is marketed without an approved FDA application.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeCapsule
Imprint200
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.795 $179.46 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $1.67 $167.33 / 100 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Sep 2022 Feb 2026 Sep 2026 $1.926 $1.673
▲ Up 6% over the last 22 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Uro-MP 118 mg/1; 40.8 mg/1; 36 mg/1; 10 mg/1; .12 mgthis 58657-0456-01 Method 100 capsules $1.795 — Availability likely —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 58657-0456-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.8K
Units reimbursed last 4 qtrs
163.5K
Gross reimbursed last 4 qtrs
$273.7K
Avg / prescription
$97.52
Avg / unit
$1.6733
Latest quarter Q4 2025
617Rx
Medicaid pays / ea
$1.6733
gross reimbursed
vs
NADAC / ea
$1.7946
acquisition cost
=
Spread
−$0.1213
-7% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
38% FFS 62% MCO
Fee-for-service · 1,071 Rx Managed care · 1,735 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 23,627 units · 200 per 100k residents OH Pennsylvania: 7,979 units · 61.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 11,095 units · 28.5 per 100k residents CA Utah: 3,558 units · 104 per 100k residents UT Colorado: 6,510 units · 111 per 100k residents CO Nebraska: no data reported NE Missouri: 3,734 units · 60.3 per 100k residents MO Kentucky: 21,541 units · 476 per 100k residents KY West Virginia: 7,512 units · 424 per 100k residents WV Virginia: 1,070 units · 12.3 per 100k residents VA Maryland: no data reported MD Connecticut: 18,101 units · 500 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,738 units · 23.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 8,577 units · 120 per 100k residents TN North Carolina: 14,195 units · 131 per 100k residents NC South Carolina: 3,211 units · 59.8 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 27,137 units · 593 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 3,961 units · 35.9 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
12.3593
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 593 /100k
2 Connecticut 500 /100k
3 Kentucky 476 /100k
4 West Virginia 424 /100k
5 Ohio 200 /100k
6 North Carolina 131 /100k
7 Tennessee 120 /100k
8 Colorado 111 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Uro-Mp — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Uro-Mp. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$3.7K
Claims incl. refills
18
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$204.44
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Uro-MP (this brand).

Top reported reactions

Anxiety5
Pain4
Headache3
Infusion Site Extravasation3
Nasopharyngitis3
Nausea3
Urinary Tract Infection3

Age at onset

Adult7
Elderly5

Reporter sex

37 reports
Male · 26%
Female · 74%

Serious outcomes

Hospitalization6
Death2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 7 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58657-0456-01 You're viewing this 100 CAPSULE in 1 BOTTLE (58657-456-01) 2014-12-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58657-456-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58657-0456-01, written without dashes as 58657045601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58657-0456-01, the first segment (58657) is the labeler code FDA assigned to Method Pharmaceuticals, LLC; the middle segment (0456) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Method Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Method Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 46 words ▾

INDICATIONS AND USAGE Uro-MP Capsules are 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 and Administration 38 words ▾

DOSAGE AND ADMINISTRATION Adults: One tablet orally 4 times per day followed by liberal fluid intake. Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.

⛔ Contraindications 64 words ▾

CONTRAINDICATIONS Uro-MP Capsules are contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and 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 68 words ▾

WARNINGS Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

WARNING: Keep this and all drugs out of reach of children. Rx Only Manufactured for: Method Pharmaceuticals, LLC Southlake, TX 76092 www.methodpharm.com Rev. 02/23

🤒 Adverse Reactions 113 words ▾

ADVERSE REACTIONS Cardiovascular - rapid pulse, flushing Central Nervous System - blurred vision, dizziness, drowsiness Respiratory - shortness of breath or troubled breathing Genitourinary - difficult micturition, acute urinary retention Gastrointestinal -dry mouth, nausea and vomiting Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue to blue-green.

This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at (877) 250-3427.

🔄 Drug Interactions ~1 min read ▾

DRUG INTERACTIONS As a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. Urinary alkalizers and thiazide diuretics: May cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Antimuscarinics: Concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications.

Antacids/antidiarrheals: Concurrent use may reduce absorption of hyoscyamine resulting in decreased therapeutic effectiveness. Concurrent use with antacids may cause urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine.

Antimyasthenics: Concurrent use with hyoscyamine may further reduce intestinal motility, therefore, caution is recommended. Ketoconazole and hyoscyamine may cause increased gastrointestinal pH. Concurrent administration with hyoscyamine may result in marked reduction in the absorption of ketoconazole.

Patients should be advised to take this combination at least 2 hours after ketoconazole. Monoamine oxidase (MAO) inhibitors: Concurrent use with hyoscyamine may intensify antimuscarinic side effects. Opioid (narcotic) analgesics may result in increased risk of severe constipation.

Sulfonamides: These drugs may precipitate with formaldehyde in the urine increasing the danger of crystalluria. Patients should be advised that the urine and/or stools may become blue to blue-green as a result of the excretion of methylene blue. Drug Abuse And Dependence A dependence on the use of Uro-MP Capsules has not been reported and due to the nature of its ingredients, abuse of Uro-MP Capsules is not expected.

🤰 Pregnancy 56 words ▾

Pregnancy/Reproduction (FDA Pregnancy Category C): Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether Uro-MP Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uro-MP Capsules should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 16 words ▾

Pediatric: Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

🧓 Geriatric Use 25 words ▾

Geriatric: Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.

🆘 Overdosage 79 words ▾

OVERDOSAGE Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children) repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control excitement and seizures.

Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70 to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic.

Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at a pH greater than 6.8.

SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine. PHENYL SALICYLATE releases salicylate, a mild analgesic for pain. METHYLENE BLUE possesses weak antiseptic properties.

It is well absorbed by the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. HYOSCYAMINE SULFATE is a parasympatholytic drug which relaxes smooth muscles and thus produces an antispasmodic effect.

It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Protein binding for hyoscyamine sulfate is moderate and biotransformation is hepatic.

📦 How Supplied / Storage and Handling 18 words ▾

HOW SUPPLIED Uro-MP Capsules are blue capsules imprinted with 200, available in bottles of 100 capsules, (NDC: 58657-456-01).

📦 Storage and Handling 43 words ▾

STORAGE Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed. Protect from moisture and direct sunlight. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

📋 Description ~2 min read ▾

DESCRIPTION Uro-MP Capsules for oral administration. Each tablet contains: Methenamine 118 mg Sodium Phosphate Monobasic 40.8 mg Phenyl Salicylate 36 mg Methylene Blue 10 mg Hyoscyamine Sulfate 0.12 mg Inactive ingredients: Lactose, Polyethylene Glycol, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, FD&C Blue # 1, FD&C Red # 3, Titanium Dioxide, Gelatin. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7 ] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin.

C 6 H 12 N 4 ; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus.

Freely soluble in water, soluble in alcohol and in chloroform. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2 NaO 4 P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules.

At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13 H 10 O 3 ; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid.

Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I.

Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16 H 18 ClN 3 S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals.

It is soluble in water and in chloroform; sparingly soluble in alcohol. HYOSCYAMINE SULFATE. [620-61-1] [3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34 H 48 N 2 O 10 S.

Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus.

Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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