Label: AZO URINARY TRACT HEALTH- phenazopyridine hydrochloride tablet

  • NDC Code(s): 49973-760-12, 49973-760-24, 49973-760-30, 49973-760-32
  • Packager: i-Health, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Phenazopyridine Hydrochloride 95 mg

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  • PURPOSE

    Purpose

    Urinary tract analgesic

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  • INDICATIONS & USAGE

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

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  • 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
    • Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
    • sensitivities to lactose

    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.

    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.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    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.
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  • OTHER SAFETY INFORMATION

    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 degrees F) in a dry place and protect from light.

    Tamper evident: Product is dealed within blisters.  Do not use if any part of the blister is torn, open or damaged.

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  • INACTIVE INGREDIENT

    ´╗┐Inactive ingredients  ´╗┐Lactose´╗┐, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, sodium starch glycolate and talc.

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  • PRINCIPAL DISPLAY PANEL

    2 Solutions for Urinary Tract Health*

    AZO

    Urinary Tract Health

    SUPPORT PACK

    Urinary Pain Relief   

    • RELIEVES PAIN, BURNING AND URGENCY
    • TARGETS THE SOURCE OF PAIN

    MOST TRUSED #1 BRAND

    18 Tablets

    95 mg Phenazopyridine Hydrochloride

    Cranberry

    • HELPS FLUSH TO MAINTAIN URINARY TRACT CLEANLINESS*
    • WITH PROBIOTIC

    14 Caplets

    Dietary Supplement

    *THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA.  THIS IF NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

    AZO 95 30

    AZO 95 24

    AZO 95 12

    AZO Support Pack Label

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  • INGREDIENTS AND APPEARANCE
    AZO URINARY TRACT HEALTH 
    phenazopyridine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49973-760
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    TALC  
    Product Characteristics
    Color brown (Maroon) Score no score
    Shape ROUND (Tablet) Size 7mm
    Flavor Imprint Code W
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49973-760-32 9 in 1 BOX
    1 2 in 1 BLISTER PACK
    2 NDC:49973-760-30 15 in 1 PACKAGE
    2 2 in 1 BLISTER PACK
    3 NDC:49973-760-24 12 in 1 PACKAGE
    3 2 in 1 BLISTER PACK
    4 NDC:49973-760-12 6 in 1 PACKAGE
    4 2 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/28/2014
    Labeler - i-Health, Inc. (061427694)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corporation 057795122 manufacture(49973-760)
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