Azo Urinary Tract Defense

Azo Urinary Tract Defense
SPL v7
SPL
SPL Set ID ba13a608-e4c5-4465-8be8-be0fd1fd46ae
Route
ORAL
Published
Effective Date 2018-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methenamine (162 mg) Salicylic Acid (162.5 mg)
Inactive Ingredients
Benzoic Acid Powdered Cellulose Croscarmellose Sodium Ferrosoferric Oxide Fd&c Red No. 40 Fd&c Yellow No. 6 Hydroxypropyl Cellulose (1600000 Wamw) Hypromelloses Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Silicon Dioxide Stearic Acid Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: AZOUD Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-11-06 Until 2018-01-31

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


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