Flavoxate Hydrochloride
Tablet · Oral
Uses
Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
Dosage and administration
Adults and children over 12 years of age One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
Contraindications
Flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
Warnings
Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
Precautions
Information for Patients Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required. Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hydrochloride have not been performed. Pregnancy Teratogenic Effects-Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate hydrochloride is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 12 years have not been established.
Side effects
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic : Urticaria and other dermatoses, eosinophilia and hyperpyrexia. Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.
Pregnancy
Pregnancy Teratogenic Effects-Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pediatric use
Pediatric Use Safety and effectiveness in children below the age of 12 years have not been established.
Overdosage
The oral LD 50 for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD 50 for flavoxate hydrochloride in mice is 1837 mg/kg. It is not known whether flavoxate hydrochloride is dialyzable.
Description
Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic. Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H -1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C 24 H 25 NO 4
• HCl. The molecular weight is 427.94. The structural formula appears below. Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin. structure-formula
How supplied
Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є58 ” on one side and plain on the other side. They are supplied as follows: NDC 24658-720-01 in bottles of 100 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 Rev. 02-2025-00 MF058REV02/25 OE2582
Patient information
Information for Patients Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.
Label text from the FDA structured product label by PuraCap Laboratories LLC dba Blu Pharmaceuticals (revised Dec 11, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Flavoxate Hydrochloride in 3 products
Flavoxate Hydrochloride NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 42806-058 | Flavoxate Hydrochloride 100 mg/1 Tablet | Epic Pharma, LLC | ANDA |
| 0574-0115 | Flavoxate Hydrochloride 100 mg/1 Tablet, Film Coated | Padagis US LLC | ANDA |
| 24658-720 | Flavoxate Hydrochloride 100 mg/1 Tablet | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA |
Frequently asked questions
What is Flavoxate Hydrochloride used for?
Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
What are the side effects of Flavoxate Hydrochloride?
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and… See the full label for the complete list.
Who makes Flavoxate Hydrochloride?
Flavoxate Hydrochloride is listed by 3 labelers in the FDA NDC directory, including Epic Pharma, LLC, Padagis US LLC, PuraCap Laboratories LLC dba Blu Pharmaceuticals.