NDC 44523-743 Ustell

Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate

NDC Product Code 44523-743

NDC Code: 44523-743

Proprietary Name: Ustell What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
S903
Score: 1

NDC Code Structure

  • 44523 - Biocomp Pharma, Inc.
    • 44523-743 - Ustell

NDC 44523-743-01

Package Description: 100 CAPSULE in 1 BOTTLE

NDC Product Information

Ustell with NDC 44523-743 is a a human prescription drug product labeled by Biocomp Pharma, Inc.. The generic name of Ustell is methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Biocomp Pharma, Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ustell Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • METHENAMINE 120 mg/1
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg/1
  • PHENYL SALICYLATE 36 mg/1
  • METHYLENE BLUE 10 mg/1
  • HYOSCYAMINE SULFATE .12 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • AMMONIA (UNII: 5138Q19F1X)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Agent - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Biocomp Pharma, Inc.
Labeler Code: 44523
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-11-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ustell Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only100 Capsules

Rx OnlyUstell© is a trademark of BioComp Pharma, Inc.Distributed by:

BIOCOMP PHARMA, INC.

San Antonio, Texas 78230
Manufactured for:

CP_T10816R0119

Description

Ustell© Capsules for oral administration
Each capsule contains:Methenamine120 mgSodium Phosphate Monobasic40.8 mgPhenyl Salicylate36 mgMethylene Blue10 mgHyoscyamine Sulfate0.12 mgHYOSCYAMINE 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
34H
48N
2O
10S. 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.
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
6H
12N
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.
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
16H
18ClN
3S; 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.
PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C
13H
10O
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.
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
2NaO
4P; 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.
Ustell© capsules contain inactive ingredients: Ammonium Hydroxide, Dicalcium Phosphate, FD&C Blue #1, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Propylene Glycol, Shellac, Silicon Dioxide, Simethicone, Stearic Acid, Titanium Dioxide.

Clinical Pharmacology

HYOSCYAMINE SULFATE is a parasympatholytic 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. Its biotransformation is hepatic. Its protein binding is moderate.METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70%-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 at a pH of 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 pH greater than 6.8.METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

Indications And Usage

Ustell
© 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.

Contraindications

Hypersensitivity to any of the ingredients is possible.Risk benefits should be carefully 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

Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.

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.

Fda Pregnancy Category C

Hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. Thus it is not known whether





Ustell™ capsules cause fetal harm when administered to a pregnant woman or can affect reproduction capacity and should be given to a pregnant woman only if clearly needed.

Breast Feeding

Problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. Accordingly,





Ustell™ capsules should be given to a nursing mother with caution and only if clearly needed.

Prolonged Use

There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to valuate carcinogenic potential.

Pediatric

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

Geriatric Use

Use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.

Adverse Reactions

Cardiovascular: rapid heartbeat, flushingCentral Nervous System: blurred vision, dizziness, drowsinessGenitourinary: difficult micturition, acute urinary retentionGastrointestinal: dry mouth, nausea and vomitingRespiratory: shortness of breath or trouble breathingSerious 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 BioComp Pharma at 1-866-762-2365 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug Interactions

Because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; 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 (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline, reducing 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); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use 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 may become blue to blue-green and the feces may be discolored as a result of the excretion of the Methylene blue.

Drug Abuse And Dependence

A dependence on the use of
Ustell
© capsules has not been reported and due to the nature of its ingredients, abuse of
Ustell
© capsules is not expected.

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 your Poison Control Center immediately. US residents can contact the

US National Poison Hotline at 1-800-222-1222.

Adults

One capsule orally 4 times per day followed by liberal fluid intake.

Older Children

Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.

How Supplied

Ustell
© capsules are blue-blue capsules imprinted with "S903". NDC 44523-743-01, Bottle of 100 capsules.

Storage

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.Store at controlled room temperature 15°-30°C (59°- 86°F).Keep in a cool, dry place.





Keep container tightly closed.





WARNING: Keep this and all drugs out of reach of children.

100 Capsule Bottle Label

NDC 44523-743-01Rx OnlyUstell©EACH CAPSULE CONTAINSMethenamine120.0 mgSodium Phosphate Monobasic40.8 mgPhenyl Salicylate36.0 mgMethylene Blue10.0 mgHyoscyamine Sulfate0.12 mg100 CapsulesUstell
© is a trademark of BioComp Pharma, Inc.
Distributed by:

BIOCOMP PHARMA, INC.

San Antonio, Texas 78230 1355

* Please review the disclaimer below.

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