Label: PHENAZOPYRIDINE HYDROCHLORIDE 200 MG- phenazopyridine hydrochloride tablet
- NDC Code(s): 70795-1252-0
- Packager: GRAXCELL PHARMACEUTICAL, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 21, 2021
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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
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INGREDIENTS AND APPEARANCE
PHENAZOPYRIDINE HYDROCHLORIDE 200 MG
phenazopyridine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70795-1252 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 200 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code G17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70795-1252-0 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/12/2020 Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)