Phenazopyridine Hydrochloride (Page 2 of 2)

ADVERSE REACTIONS

The following adverse events have been reported:

CNS: headache.

Gastrointestinal: nausea, vomiting and diarrhea.

Dermatologic and Hypersensitivity: rash, pruritus, discoloration, anaphylactoid-like reaction and hypersensitivity hepatitis.

Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6-PD deficiency, sulfhemoglobinemia.

Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, discoloration of body fluids and aseptic meningitis.

HOW SUPPLIED

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].

Distributed in 1 bottle of 100 tablets.

NDC 69367-162-04 100 mg, 100 count — Appearance: Reddish-brown, round, film coated tablets debossed “812” on one side and plain on the other.

NDC 69367-163-04 200 mg, 100 count — Appearance: Reddish-brown, round, film coated tablets debossed “813” on one side and plain on the other.

To report an adverse reaction, please contact Westminster Pharmaceuticals, LLC at 1-844-221-7294

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Rev. 01/20

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 69367-162-04

RX Only

Phenazopyridine
Hydrochloride
Tablets, USP

100 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

NDC 69367-163-04

RX Only

Phenazopyridine
Hydrochloride
Tablets, USP

200 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 200 mg Tablet Bottle Label
(click image for full-size original)
PHENAZOPYRIDINE HYDROCHLORIDE
phenazopyridine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
POVIDONE K30
TALC
Product Characteristics
Color BROWN (Reddish-Brown) Score score with uneven pieces
Shape ROUND Size 7mm
Flavor Imprint Code 812
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-162-04 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/10/2016
PHENAZOPYRIDINE HYDROCHLORIDE
phenazopyridine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
POVIDONE K30
TALC
Product Characteristics
Color BROWN (Reddish-Brown) Score score with uneven pieces
Shape ROUND Size 10mm
Flavor Imprint Code 813
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-163-04 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/10/2016
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 12/2018 Westminster Pharmaceuticals, LLC

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.