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 ADMINISTRATION section.)
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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.
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HOW SUPPLIED
100 mg Tablets: Supplied in bottles of 10 (NDC 00440-2070-10) counts.
Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “1” on one side and plain on the other.
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DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.
STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Manufactured by:
Amneal Pharmaceuticals
Paterson, NJ 07504
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
Rev. 08-2010
Repackaged By: Aidarex Pharmaceuticals LLC, Corona, CA 92880
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