AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]

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AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]
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NDC 49973-301-30, 49973-301-31, 49973-301-32
Set ID 3d0298b7-eaec-488b-9cab-19af4614ff53
Category HUMAN OTC DRUG LABEL
Packager i-Health, Inc.
Generic Name
Product Class
Product Number
Application Number
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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 BOX05/24/201212/01/2020
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49973-301-321 in 1 BOX11/11/201711/30/2020
    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)
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