Label: PHENAZOPYRIDINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 10135-620-01, 10135-621-01
  • Packager: Marlex Pharmaceuticals Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 12, 2021

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  • SPL UNCLASSIFIED SECTION

    PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP

    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:

    The structural formula of Phenazopyridine Hydrochloride.

    Inactive Ingredients: Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Povidone, Polyethylene Glycol and Pregelatinized Starch.

  • 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.

  • 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 in pregnant women. Because animal reproduction 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 100 (NDC 10135-0620-01) counts.

    Appearance: Deep brown to maroon colored, round, film coated tablets debossed “PY” above “1” on one side and plain on the other.

    200 mg Tablets: Supplied in bottles of 100 (NDC 10135-0621-01) counts.

    Appearance: Deep brown to maroon colored, round, film coated tablets debossed “PY” above “2” on one side and plain on the other.

    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].

    Manufactured for:
    Marlex Pharmaceuticals, Inc.
    New Castle, DE 19720

    Distributed by:
    Marlex Pharmaceuticals, Inc.
    New Castle, DE 19720

    Made in USA

    Rev.2 03/18AN 

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0620-01
    Phenazopyridine

    Hydrochloride

    Tablets, USP
    100 mg

    Rx Only

    100 TABLETS

    NDC 10135-0620-01
Phenazopyridine
Hydrochloride
Tablets, USP
100 mg
Rx Only
100 TABLETS

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0621-01
    Phenazopyridine

    Hydrochloride

    Tablets, USP
    200 mg

    Rx Only

    100 TABLETS

    NDC 10135-0621-01
Phenazopyridine
Hydrochloride
Tablets, USP
200 mg
Rx Only
100 TABLETS

  • INGREDIENTS AND APPEARANCE
    PHENAZOPYRIDINE HYDROCHLORIDE 
    phenazopyridine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10135-620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (Deep brown to maroon colored) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code PY;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-620-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2016
    PHENAZOPYRIDINE HYDROCHLORIDE 
    phenazopyridine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10135-621
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (Deep brown to maroon colored) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code PY;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-621-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2016
    Labeler - Marlex Pharmaceuticals Inc (782540215)