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

R_X Only

Phenazopyridine
Hydrochloride
Tablets, USP

100 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

NDC 69367-163-04

R_X Only

Phenazopyridine
Hydrochloride
Tablets, USP

200 mg

100 Tablets

Westminster
Pharmaceuticals

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