Phenazopyridine HCL 200 mg/1
Phenazopyridine HCL · TABLET · Direct Rx
Phenazopyridine HCL is a tablet containing phenazopyridine hcl at 200 mg/1, taken oral. Manufactured by Direct Rx.
Key Facts
- Brand Name
- Phenazopyridine HCL
- Generic Name
- Phenazopyridine HCL
- NDC Code (Product)
72189-530- Manufacturer
- Direct Rx
- Strength
- 200 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Marketing Start
- 01/05/2024
Recall History
Winder Laboratories, LLC
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
RemedyRepack Inc.
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Full Prescribing Information
Indications & Usage
Phenazopyridine Hydrochloride is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine Hydrochloride for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine Hydrochloride is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine Hydrochloride should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine Hydrochloride and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See DOSAGE AND ADMINISTRATION.)
Dosage & Administration
100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine Hydrochloride should not exceed 2 days.
Warnings
Phenazopyridine Hydrochloride is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals (IARC 1980, 1982, 1987, NCI 1978). When administered in the diet, Phenazopyridine hydrochloride increased the incidences of hepatocellular adenomas and carcinomas in female mice and adenomas and adenocarcinomas of the colon and rectum in rats of both sexes. There is inadequate evidence for the carcinogenicity of Phenazopyridine hydrochloride in humans (TARC 1987). In one limited epidemiological study, no significant excess of any cancer was observed among 2,214 patients who received Phenazopyridine hydrochloride and were followed for a minimum of 3 years.
Contraindications
Phenazopyridine Hydrochloride should not be used in patients who are hypersensitive to the drug or its ingredients. Phenazopyridine Hydrochloride is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis or pyelonephritis of pregnancy. It should be used cautiously in the presence of GI disturbances.
Adverse Reactions
The following adverse events have been reported: CNS: headache. Gastrointestinal: nausea, vomiting and diarrhea. Dermatologic and Hypersensitivity: rash, pruritus, discoloration, anaphylactoid-like reaction and hypersensitivity hepatitis. Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6-PD deficiency, sulfhemoglobinemia. Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, discoloration of body fluids and aseptic meningitis.
Frequently Asked Questions
What is Phenazopyridine HCL used for?
Phenazopyridine HCL contains Phenazopyridine HCL. It is a tablet taken oral. Consult your doctor for specific uses.
Is Phenazopyridine HCL a controlled substance?
Phenazopyridine HCL is not classified as a controlled substance by the DEA.
What is the generic name for Phenazopyridine HCL?
The generic name for Phenazopyridine HCL is Phenazopyridine HCL. There are no other listed brand versions of Phenazopyridine HCL.
What is the NDC code for Phenazopyridine HCL 200 mg/1?
The NDC (National Drug Code) for Phenazopyridine HCL 200 mg/1 is 72189-530, listed by Direct Rx.
Other Phenazopyridine HCL Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)