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

Appearance: Reddish-brown, round, film coated tablets debossed “813” on one side and plain on the other.

NDC: 70518-2169-00

NDC: 70518-2169-01

NDC: 70518-2169-02

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 6 in 1 BOTTLE PLASTIC

PACKAGING: 21 in 1 BOTTLE PLASTIC

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].

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Phenazopyridine Hydrochloride

GENERIC: Phenazopyridine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2169-0

NDC: 70518-2169-1

NDC: 70518-2169-2

COLOR: brown

SHAPE: ROUND

SIZE: 10 mm

IMPRINT: 813

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 6 in 1 BOTTLE PLASTIC

PACKAGING: 21 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

• PHENAZOPYRIDINE HYDROCHLORIDE 200mg in 1

INACTIVE INGREDIENT(S):

• CROSCARMELLOSE SODIUM
• MICROCRYSTALLINE CELLULOSE
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POLYSORBATE 80
• POLYVINYL ALCOHOL, UNSPECIFIED
• STARCH, CORN
• POVIDONE K30
• TALC

PHENAZOPYRIDINE HYDROCHLORIDE phenazopyridine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2169(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:70518-2169-0 30 TABLET, FILM COATED in 1 BLISTER PACK None 2 NDC:70518-2169-1 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None 3 NDC:70518-2169-2 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/28/2019

Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2022 REMEDYREPACK INC.