Label: AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION- methenamine, sodium salicylate tablet

  • NDC Code(s): 49973-011-04, 49973-011-18, 49973-011-24
  • Packager: i-Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 December 12, 2020

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

  • Drug Facts

    Active Ingredients (in each tablet):

    Methenamine 162 mg

    Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)

  • PURPOSE

    Purpose

    Antibacterial

    Analgesic (pain reliever)

  • INDICATIONS & USAGE

    Uses  Temporarily relieves:

    • pain & burning
    • frequency and urgency of urination
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.  If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. 

    Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.  The chance is higher if you:

    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
    • have 3 or more alcoholic drinks every day while using this product
    • have stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take more or for a longer time than directed 

    Do not use: 

    • if you are on a sodium restricted diet 
    • if you are allergic to salicylates (including aspirin) unless directed by a doctor
    • if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor

    Ask a doctor before use if you have 

    • frequent, burning urination for the first time
    • the stomach bleeding warning applying to you
    • history of stomach problems, such as heartburn
    • high blood pressure
    • heart disease
    • liver cirrhosis
    • bleeding problems
    • diuretic use
    • ulcers
    • kidney disease
    • reached age 60 or older

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug 

    When using this product do not take more than the recommended dosage

    Stop and ask a doctor if 

    • product has been used for 3 days
    • you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have blood or black stools, have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day.  Drink plenty of fluids.  Children under 12 years: ask a doctor. 

  • OTHER SAFETY INFORMATION

    Other Information:

    • each tablet contains 25 mg of sodium
    • store at 59-86°F (15-30°C) in a dry place
    • protect from light
    • Tamper evidence tablets sealed in blisters.  Do not use if blister foil or seal is open or damaged.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzoic Acid, Cellulose, Croscarmellose Sodium, Edible black ink, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Magnesium Stearate, Methacrylic Acid - Ethyl Acrylate Copolymer, Silica, Stearic Acid, Titanium Dioxide, Triethyl Citrate

  • PRINCIPAL DISPLAY PANEL

    AZO 

    Urinary Tract Defense

    Antibacterial Protection*

    Antibacterial Urinary Pain Relief

    Methenamine and Sodium Salicylate (NSAID)

    * Helps inhibit the progression of infection until you see your healthcare professional.  AZO is not intended to replace medical care. 

    Azo UDT 24

    Azo UDT Pouch

    Azo UDT 18

  • INGREDIENTS AND APPEARANCE
    AZO URINARY TRACT DEFENSE  ANTIBACTERIAL PROTECTION
    methenamine, sodium salicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE162 mg
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE162.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AZOUD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49973-011-241 in 1 BOX03/01/2016
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49973-011-181 in 1 BOX04/23/2018
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49973-011-044 in 1 POUCH; Type 0: Not a Combination Product11/06/201501/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/06/2015
    Labeler - i-Health, Inc. (061427694)