Label: NUVICARE-URINARY PAIN RELIEF MAXIMUM STRENGTH- phenazopyridine hydrochloride tablet

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

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Drug Label Information

Updated August 3, 2026

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  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg

  • Purpose

    Urinary tract analgesic

  • Use

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

  • Warnings

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

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ kidney disease

    ■ allergies to foods, preservatives or dyes

    ■ had a hypersensitive reaction to Phenazopyridine Hydrochloride.

  • WHEN USING

    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

    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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    In case of an overdose, get medical help or contact a Poison Control Center (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

    WARNING:

    ■ This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer

    ■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

    ■This product may stain soft contact lenses and other items if handled after touching tablets

    ■Store at room temperature (59º-86ºF) in a dry place and protect from light

  • Inactive ingredients

    carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.

  • Questions or comments?

    Call +1 (877) 413 1632 or email: support@nuvicare.com

  • SPL UNCLASSIFIED SECTION

    †This product is neither manufactured nor distributed by i-Health, Inc., the distributor of AZO Urinary Pain Relief®
    Maximum Strength.
    Distributed by: Nuvicare LLC., Brooklyn, NY 11211, U.S.A.
    www.nuvicare.com

  • NDC 84324-042-01

    L205-00 NC Urinary Maximum Pain Relief

  • INGREDIENTS AND APPEARANCE
    NUVICARE-URINARY PAIN RELIEF MAXIMUM STRENGTH 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-042
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorbrown (Maroon) Scoreno score
    ShapecapsuleSize9mm
    FlavorImprint Code p99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84324-042-011 in 1 CARTON08/04/2026
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/04/2026
    Labeler - NUVICARE LLC (119257565)
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