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AZO Urinary Tract Defense 



Drug Facts

Active Ingredients (in each tablet):

Methenamine 162 mg

Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)


OTC - PURPOSE SECTION

Purpose

Antibacterial

Analgesic (pain reliever)


INDICATIONS & USAGE SECTION

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 

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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 

OTC - WHEN USING SECTION

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


OTC - STOP USE SECTION

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

PREGNANCY SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


DOSAGE & ADMINISTRATION SECTION

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 SECTION

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


PACKAGE LABEL.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.