Label: AZO- urinary pain relief tablet

  • NDC Code(s): 49973-301-30, 49973-301-31, 49973-301-32
  • Packager: i-Health, Inc.
  • 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 January 10, 2019

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  • Drug Facts

    Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 95 mg

  • PURPOSE

    Purpose

    Urinary analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings  Please read insert for important precautions.

    Ask a doctor before use if you have

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

    Caution: Do not use this product 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 doctor 

    • your symptoms last for more than 2 days
    • you suspect you are having an adverse reaction to the medication.
  • 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years or 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.
  • GENERAL PRECAUTIONS

    Other Information

    • 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 (59-86 F) in a dry place and protect from light
    • Tamper evident: tablets sealed in blisters.  Do not use if blister foil or seal is open or damaged.
  • INACTIVE INGREDIENT

    Inactive ingredientsmicrocrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate.  May also contain corn starch.

  • QUESTIONS

    Distributed by i-Health, Inc.

    55 Sebethe Drive, Cromwell, CT 06416

    Made in India.

    Most Trusted Brand based on Nielsen data through 3/23/2013.

    For questions, concerns, or to report an adverse event, call (800) 722-3476

    www.azoproducts.com

  • PRINCIPAL DISPLAY PANEL

    AZO  

    Urinary Pain Relief 

    • Relieves pain, burning & urgency
    • Targets the source of pain 

    #1 Most Trusted Brand

    Tablets

    95 mg Phenazopyridine Hydrochloride

    AZO UPR Label Combined

    AZO UPR 95

  • INGREDIENTS AND APPEARANCE
    AZO 
    urinary pain relief tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-301
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorbrown (Maroon) Scoreno score
    ShapeROUND (Tablet) Size7mm
    FlavorImprint Code W
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49973-301-3115 in 1 BOX05/24/2012
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49973-301-3015 in 1 BOX05/24/2012
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49973-301-321 in 1 BOX11/11/2017
    318 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/24/2012
    Labeler - i-Health, Inc. (061427694)