Azo Urinary Tract Defense
ba13a608-e4c5-4465-8be8-be0fd1fd46ae
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredients (in each tablet): Methenamine 162 mg Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)
Medication Information
Indications and Usage
Uses Temporarily relieves:
- pain & burning
- frequency and urgency of urination
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.
Description
Active Ingredients (in each tablet): Methenamine 162 mg Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)
Section 42228-7
If pregnant or breast feeding, ask a health professional before use.
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
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
Section 50567-7
When using this product do not take more than the recommended dosage
Section 50568-5
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
Section 50569-3
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
Section 50570-1
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
Section 51727-6
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
Section 51945-4
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.
Section 55105-1
Purpose
Antibacterial
Analgesic (pain reliever)
Section 60561-8
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.
Drug Facts
Active Ingredients (in each tablet):
Methenamine 162 mg
Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)
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
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
Structured Label Content
Indications and Usage (34067-9)
Uses Temporarily relieves:
- pain & burning
- frequency and urgency of urination
Dosage and Administration (34068-7)
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.
Section 42228-7 (42228-7)
If pregnant or breast feeding, ask a health professional before use.
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product do not take more than the recommended dosage
Section 50568-5 (50568-5)
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
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
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
Section 51945-4 (51945-4)
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.
Section 55105-1 (55105-1)
Purpose
Antibacterial
Analgesic (pain reliever)
Section 60561-8 (60561-8)
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.
Drug Facts
Active Ingredients (in each tablet):
Methenamine 162 mg
Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)
warnings (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
Distributed By and Contact Information (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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:21.354241 · Updated: 2026-03-14T23:10:42.831626