Phenazopyridine Hydrochloride: Package Insert and Label Information

PHENAZOPYRIDINE HYDROCHLORIDE- phenazopyridine hydrochloride tablet, coated
Nationwide Laboratories, LLC

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Rx Only

CAUTION

Federal law prohibits dispensing without prescription.

DESCRIPTION

Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula.

Chemical Structure
(click image for full-size original)

Inactive Ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Propylene Glycol and Silicon Dioxide.

CLINICAL PHARMACOLOGY

Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is not known.

The pharmacokinetic properties of Phenazopyridine HCl have not been determined. Phenazopyridine HCl is rapidly excreted by the kidneys, with as much as 66% of an oral dose being excreted unchanged in the urine.

Phenazopyridine Hydrochloride Indications and Usage

Phenazopyridine HCl 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 2 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 2 days. (See DOSAGE AND ADMINISTRATION section).

CONTRAINDICATIONS

Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to It. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.

ADVERSE REACTIONS

Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section).

PRECAUTIONS

General

A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind.

NOTE : Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

Laboratory Test Interaction

Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Pregnancy Category B

Reproduction studies have been performed in rats at doses up to 50 mg/Kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies pregnant women. Because animal production studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.

DOSAGE AND ADMINISTRATION

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.

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.

OVERDOSAGE

Exceeding the recommended dose in patients with good renal function or administering the usual 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/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and “bite cells” (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

HOW SUPPLIED

100 mg Tablets: Supplied in bottles of
100ct (NDC 42937-701-10)
250ct (NDC 42937-701-16)

Appearance: Reddish-brown, round, film coated tablets, debossed “701” on one side and plain on other side.

200 mg Tablets: Supplied in bottles of
100ct (NDC 42937-702–10)
250ct (NDC 42937-702-16)

Appearance: Reddish-brown, round, film coated tablets, debossed “702” on one side and plain on other side.

DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

STORE at 20° -25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP controlled Room Temperature].

Manufactured for:
Nationwide Laboratories LLC
Iselin, NJ 08830
(732) 682-2501

Rev. 04-2012

PRINCIPAL DISPLAY PANEL — 100 mg Bottle Label

Nationwide Laboratories LLC

NDC 42937-701-10

Phenazopyridine
Hydrochloride
Tablets, USP

100 mg

Rx only

100 Tablets

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

PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label

Nationwide Laboratories LLC

NDC 42937-702-10

Phenazopyridine
Hydrochloride
Tablets, USP

200 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL -- 200 mg Bottle Label
(click image for full-size original)
PHENAZOPYRIDINE HYDROCHLORIDE
phenazopyridine hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42937-701
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
Starch, Corn
Croscarmellose Sodium
HYPROMELLOSE, UNSPECIFIED
Magnesium Stearate
MICROCRYSTALLINE CELLULOSE
Mineral Oil
POVIDONE, UNSPECIFIED
Propylene Glycol
Silicon Dioxide
Product Characteristics
Color BROWN (Reddish-brown) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 701
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42937-701-10 100 TABLET, COATED in 1 BOTTLE None
2 NDC:42937-701-16 250 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/02/2011
PHENAZOPYRIDINE HYDROCHLORIDE
phenazopyridine hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42937-702
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
Starch, Corn
Croscarmellose Sodium
HYPROMELLOSE, UNSPECIFIED
Magnesium Stearate
MICROCRYSTALLINE CELLULOSE
Mineral Oil
POVIDONE, UNSPECIFIED
Propylene Glycol
Silicon Dioxide
Product Characteristics
Color BROWN (Reddish-brown) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 702
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42937-702-10 100 TABLET, COATED in 1 BOTTLE None
2 NDC:42937-702-16 250 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/02/2011
Labeler — Nationwide Laboratories, LLC (078366153)

Revised: 02/2020 Nationwide Laboratories, LLC

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