FDA Label for Azo Urinary Tract Defense Antibacterial Protection

Drug Facts

Active Ingredients (in each tablet):

Methenamine 162 mg

Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)

Otc - 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 

Otc - Do Not Use

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

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

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

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

Otc - Stop Use

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

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

Otc - Keep Out Of Reach Of Children

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

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.