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  5. Label Information: Phenazopyridine Hydrochloride 200 Mg

FDA Label for Phenazopyridine Hydrochloride 200 Mg

View Indications, Usage & Precautions

Table of Contents

    1. INDICATIONS AND USAGE
    2. DOSAGE AND ADMINISTRATION
    3. INACTIVE INGREDIENTS
    4. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phenazopyridine Hydrochloride 200 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Graxcell Pharmaceutical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Indications And Usage



Phenazopyridine 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 two 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 two days. (See DOSAGE AND ADMINISTRATION section.)


Dosage And Administration



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.


Inactive Ingredients



Phenazopyridine HCl Tablets, USP contains the following
inactive ingredients: croscarmellose sodium, colloidal silicon
dioxide, hydroxypropyl methyl cellulose, magnesium stearate,
maize (corn starch) microcrystalline cellulose, polyethylene
glycol, povidone and pregelatinized starch.


Package Label.Principal Display Panel




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