Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate

FDA Drug Information • Also known as: Uribel Tabs

Brand Names
Uribel Tabs
Drug Class
Nitrogen Binding Agent [EPC]
Route
ORAL
Dosage Form
TABLET, COATED
Product Type
HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Uribel® Tabs for oral administration Each tablet contains: Methenamine .........................................................................................................................81.6 mg Benzoic Acid ..........................................................................................................................9.0 mg Phenyl Salicylate ...................................................................................................................36.2 mg Methylene Blue ......................................................................................................................10.8 mg Hyoscyamine Sulfate..............................................................................................................0.12 mg 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. 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 hexamethyleneimine; 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. 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...

What Is Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Used For?

INDICATIONS AND USAGE Uribel Tabs 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

DOSAGE AND ADMINISTRATION Adults One tablet 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.

Warnings and Precautions

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

Contraindications

CONTRADICTIONS 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).

Overdosage

OVERDOSE 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 local Poison Control Center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

How Supplied

HOW SUPPLIED Uribel Tabs are blue tablets imprinted with “SAT” on one side and “109” on opposite side. NDC 0178-0745-01, bottle of 100 tablets.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.