PHENAZOPYRIDINE HYDROCHLORIDE  200 MG- phenazopyridine hydrochloride tablet 
GRAXCELL PHARMACEUTICAL, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Phenazopyridine Hydrochloride tablet, film coated - 200 mg, 70795-1252

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.

01b LBL_Phenazopyridine HCl 200mg_100 ct_front

01b LBL_Phenazopyridine HCl 100mg_insert_Page_1

01b LBL_Phenazopyridine HCl 100mg_insert_Page_2

01b LBL_Phenazopyridine HCl 100mg_insert_Page_3

01b LBL_Phenazopyridine HCl 100mg_insert_Page_401b LBL_Phenazopyridine HCl 100mg_insert_Page_5

PHENAZOPYRIDINE HYDROCHLORIDE   200 MG
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70795-1252
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70795-1252-0100 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/12/2020
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Revised: 12/2021
Document Id: d3adc8a7-43f7-9a98-e053-2995a90a4357
Set id: 6ffd238d-cef1-46c8-bff3-83887fcdf33b
Version: 4
Effective Time: 20211221
 
GRAXCELL PHARMACEUTICAL, LLC