Phenazopyridine Hydrochloride 100 mg/1
Phenazopyridine · TABLET · Northwind Health Company, LLC
Phenazopyridine Hydrochloride is a tablet containing phenazopyridine at 100 mg/1, taken oral. Manufactured by Northwind Health Company, LLC.
Key Facts
- Brand Name
- Phenazopyridine Hydrochloride
- Generic Name
- Phenazopyridine
- NDC Code (Product)
51655-007- Manufacturer
- Northwind Health Company, LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Marketing Start
- 08/05/2022
Recall History
Nationwide Laboratories, LLC
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Nationwide Laboratories, LLC
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRAT…
Dosage & Administration
DOSAGE AND 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 HCl should not exceed 2 days.
Contraindications
CONTRAINDICATIONS Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.
Adverse Reactions
ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section ).
Frequently Asked Questions
What is Phenazopyridine Hydrochloride used for?
Phenazopyridine Hydrochloride contains Phenazopyridine. It is a tablet taken oral. Consult your doctor for specific uses.
Is Phenazopyridine Hydrochloride a controlled substance?
Phenazopyridine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Phenazopyridine Hydrochloride?
The generic name for Phenazopyridine Hydrochloride is Phenazopyridine. There are 8 other brand versions of Phenazopyridine.
What is the NDC code for Phenazopyridine Hydrochloride 100 mg/1?
The NDC (National Drug Code) for Phenazopyridine Hydrochloride 100 mg/1 is 51655-007, listed by Northwind Health Company, LLC.
Other Phenazopyridine Brands
See all →- Maximum Strength Urinary Pain Relief99.5 mg/180513-517
- Quality Choice Urinary Pain Relief95 mg/183324-201
- TopCare Urinary Pain Relief95 mg/136800-040
- Discount Drugmart Maximum Strength Urinary Pain Relief99.5 mg/153943-336
- PHENAZOPYRIDINE HYDROCHLORIDE95 mg/168071-2273
- Sunmark Maximum Strength Urinary Pain Relief99.5 mg/170677-0078
- GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet99.5 mg/170692-178
- Rugby Phenazopyridine HCl Urinary Tract Analgesic95 mg/10536-1411
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)