Phenazopyridine hydrochloride 100 MG Oral Tablet
INDICATIONS AND USAGE Phenazopyridine HCl 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 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 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 should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See DOSAGE AND ADMINISTRATION.)
Acella Pharmaceuticals, LLC
ROUND BROWN 801
801 ROUND BROWN
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HOW SUPPLIED 100 mg tablets: Supplied in bottles of 100. Deep brown to maroon colored, round, film coated tablets debossed “801” on one side and plain on the other. NDC# 42192-801-01. 200 mg tablets: Supplied in bottles of 100. Deep brown to maroon colored, round, film coated tablets debossed “802” on one side and plain on the other. NDC# 42192-802-01. Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein. RX ONLY Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30022 Rev 0316-02
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