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 49973-244-02, 49973-244-12, 49973-244-24
Set ID 4eab55aa-2087-4b66-92d7-5d8449f96042
Category HUMAN OTC DRUG LABEL
Packager i-Health, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 97.5 mg

  • PURPOSE

    Purpose

    Urinary tract 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.

    Do not use 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 if

    • 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.  In case of an overdose, get medical help or contact a Poison Control Center right away.

    If pregnant or breastfeeding, as a professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. 

  • 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.
    • Children under 12: Do not use without consulting a doctor
    • Do not use for more than 2 days (12 tablets) 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.
    • Carcinogenesis: Long-term administration of Phenazopyridine Hydrochloride 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.
  • INACTIVE INGREDIENT

    Inactive ingredients microcrystalline 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.

    ϯNeilsen data through January 26, 2013.

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

    www.azoproducts.com

  • PRINCIPAL DISPLAY PANEL

    Fast Effective Pain Relief

    AZO
    Urinary Pain Relief


    MAXIMUM STRENGTH
    MORE ACTIVE INGREDIENT RELIEVES PAIN, BURNING & URGENCY
    TARGETS THE SOURCE OF PAIN

    #1 MOST TRUSTED BRAND

    Tablets
    97.5 mg Phenazopyridine Hydrochloride

    Azo 24

    Azo 12

    Azo 2 Pouch

  • INGREDIENTS AND APPEARANCE
    AZO 
    urinary pain relief tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-244
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenazopyridine Hydrochloride (UNII: 0EWG668W17) (Phenazopyridine - UNII:K2J09EMJ52) Phenazopyridine Hydrochloride97.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVAL (Tablet) Size8mm
    FlavorImprint Code WX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49973-244-126 in 1 BOX05/18/2012
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49973-244-2412 in 1 BOX05/18/2012
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49973-244-022 in 1 POUCH; Type 0: Not a Combination Product12/28/201710/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/18/2012
    Labeler - i-Health, Inc. (061427694)
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