Label: PHENAZOPYRIDINE HYDROCHLORIDE tablet

  • NDC Code(s): 50696-003-01
  • Packager: GPT Pharmaceuticals Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 12, 2026

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg

  • Purpose

    Urinary tract analgesic

  • Uses

    Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

  • Warnings

    Do not exceed recommended dosage.

    Ask a doctor before use if you have

    • kidney disease
    • allergies to foods, preservatives or dyes
    • had a hypersensitive reaction to Phenazopyridine Hydrochloride

    Do not use

    if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

    When using this product

    • stomach upset may occur, taking this product with or after meals may reduce stomach upset
    • your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

    Stop use and ask a doctor if

    • your symptoms last for more than 2 days
    • you suspect you are having an adverse reaction to the medication
    • long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

    If pregnant or breastfeeding,

    ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

    Keep out of reach of children.

    In case of an overdose, get medical help or contact a Poison Control Center call (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years and older:Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor
    Children under 12:Do not use without consulting a doctor

  • Other information

    • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
    • This product may stain contact lenses and other items if handled after touching tablets.
    • Store in a tightly closed container
  • Inactive ingredients

    colloidal silicone dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, maize (corn) starch, microcrystalline cellulose, povidone, pregelatinized starch

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PHENAZOPYRIDINE HYDROCHLORIDE 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50696-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code WM7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50696-003-0125000 in 1 DRUM; Type 0: Not a Combination Product05/01/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2026
    Labeler - GPT Pharmaceuticals Private Limited (650484871)
    Registrant - GPT Pharmaceuticals Private Limited (650484871)
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