Phenazopyridine HCl 100mg (Page 2 of 2)

OVERDOSAGE

Symptoms: Exceeding the recommended dose in patients with normal renal function or administering the recommended dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/dose given i.v. as a 1% solution as needed, should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia also may occur, and “bite cells” (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis; however, hemolysis may occur at normal doses in patients with G-6-PD Mediterranean.

Renal toxicity and occasional failure and hepatic impairment may also occur.

Treatment: Treatment is symptomatic and supportive.

DOSAGE AND ADMINISTRATION

Adults: 200 mg 3 times daily after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of phenazopyridine should not exceed 2 days. If symptoms persist, the patient should be re-evaluated.

HOW SUPPLIED

Product: 50436-0450

NDC: 50436-0450-1 9 TABLET in a BOTTLE

PHENAZOPYRIDINE HCL 100MG (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET

Label Image
(click image for full-size original)
PHENAZOPYRIDINE HCL 100MG
phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-0450(NDC:58657-450)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
MAGNESIUM STEARATE
Product Characteristics
Color BROWN (Reddish-brown) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code J1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-0450-1 9 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/31/2014
Labeler — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-0450), RELABEL (50436-0450)

Revised: 12/2018 Unit Dose Services

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 © 2022. All Rights Reserved.