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FDA LABEL GENERIC: Methenamine MFR: i-Health, Inc.

Azo Urinary Tract Defense (methenamine 162 Mg / Sodium Salicylate 162.5 Mg) Oral Tablet

Active Ingredients (in each tablet):

Methenamine 162 mg

Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)

Purpose

Antibacterial

Analgesic (pain reliever)

INDICATIONS AND 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

USE IN SPECIFIC POPULATIONS

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 AND 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 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 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

Distributed by and Contact Information

Distributed by i-Health, Inc., 25 Bacon Road, Enfield, CT 06082
For Questions or Concerns: 800-722-3476 or Visit azoproducts.com

ASK A DOCTOR

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.