Label: URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 95 mg

  • Purpose

    Urinary tract analgesic

  • Uses

    Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

  • Warnings

    Do not exceed recommended dosage

    Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

    Ask a doctor before use if you have

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

    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 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.

    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 right away.

  • Directions

    • Adults and children 12 years and over: 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 years: 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 at room temperature between 15°C -30°C (59°F -86°F) in a dry place and protect from light.
  • Inactive ingredients

    colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate

  • Questions or comments?

    call 1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY THE KROGER CO.
    CINCINNATI, OHIO 45202

  • PRINCIPAL DISPLAY PANEL - 95 mg Tablet Blister Pack Carton

    *Compare to active ingredient of AZO® URINARY
    PAIN RELIEF MAXIMUM STRENGTH *see back panel
    NDC XXXXX-XXX-XX

    Urinary
    Pain Relief

    Phenazopyridine
    Hydrochloride 95 mg

    FAST RELIEF
    FOR URINARY
    DISCONFORT

    actual
    size

    30 TABLETS

    PRINCIPAL DISPLAY PANEL - 95 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-757
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code S159
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-757-301 in 1 CARTON05/01/2021
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER05/01/2021
    Labeler - KROGER COMPANY (006999528)
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