Label: MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 1, 2024

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  • Drug Facts

  • 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 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 useif 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 right away.

  • 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 (59ºF -86ºF) in a dry place and protect from light.

  • 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 years:Do not use without consulting a doctor

  • Inactive ingredients

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

  • Questions?

    call toll-free 1-800-630-8895

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in  AZO Urinary Pain Relief ®Maximum Strength*  

    NDC 80513-517-72

    Maximum Strength Urinary Pain Relief

    99.5 mg Phenazopyridine Hydrochloride

    #1 DOCTOR RECOMMENDED OTC INGREDIENT FOR UTI PAIN

    TEMPORARY RELIEF OF URINARY PAIN, BURNING & URGENCY

    Urinary Analgesic

    72 Tablets

    DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

    Size and color of tablet may very.

    WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

    *This product is not manufactured or distributed by I-Health, Inc., owner of the registered trademark of AZO Urinary Pain Relief ®Maximum Strength

    Distributed by:

    ADVANCED RX LLC,

    1942 NE 163rd St North Miami Beach,

    FL 33162 U.S.A.

    MADE IN USA

    label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-517
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code SP9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-517-7272 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2024
    Labeler - Advanced Rx LLC (042795108)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC.116840615manufacture(80513-517)