Azo urinary tract defense antibacterial plus urinary pain relief tablets

• 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

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.