Description
Azo urinary tract defense antibacterial plus urinary pain relief. Helps control the infection. Plus general pain reliever. Helps inhibit the progression of the infection until you see a healthcare professional. Azo is not intended to replace medical care.
Directions
Adult 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.
Ingredients
Active Ingredients: Methenamine (162 mg), Sodium Salicylate (162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)) Inactive Ingredients: Benzoic Acid, Cellulose, Croscarmellose Sodium, Edible Black Ink, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellose, Magnesium Stearate, Methacrylic Acid-Ethyl Acrylate Copolymer, Silica, Stearic Acid, Titanium Dioxide, Triethyl Citrate
WARNINGS
Reye's syndrome: Children and teenagers who have or 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 a NSAID, which may cause stomach bleeding. The chance is higher if you: Take Drug 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 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 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 Heart Burn 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 use & 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 Bloody or Black Stools Have Stomach Pain That Does Not Get Better Ringing in the Ears or a Loss Of Hearing Occurs If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medial help or contact a Poison Control Center right away.
Updated December 12, 2020 If you are a consumer or patient please visit
this version. Active Ingredients (in each tablet):
Methenamine 162 mg Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug) Purpose Antibacterial Analgesic (pain reliever) Uses Temporarily relieves: Drug Label Information
- pain & burning
- frequency and urgency of urination
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.
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
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.
View Labeling Archives for this drug
AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION- methenamine, sodium salicylate tablet
Number of versions: 5
Dec 18, 2020 | 5 (current) | download |
Dec 30, 2019 | 4 | download |
Jan 2, 2019 | 3 | download |
Apr 23, 2018 | 2 | download |
Nov 12, 2015 | 1 | download |
RxNorm
AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION- methenamine, sodium salicylate tablet
1 | 1489932 | methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet | PSN |
2 | 1489932 | methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet | SCD |
3 | 1721434 | Azo Urinary Tract Defense 162 MG / 162.5 MG Oral Tablet | PSN |
4 | 1721434 | methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet [Azo Urinary Tract Defense] | SBD |
5 | 1721434 | Azo Urinary Tract Defense (methenamine 162 MG / sodium salicylate 162.5 MG) Oral Tablet | SY |
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NDC Codes
AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION- methenamine, sodium salicylate tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
1 | 49973-011-04 |
2 | 49973-011-18 |
3 | 49973-011-24 |