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NDC 49973-0011-18 Azo Urinary Tract Defense 162; 162.5 mg/1; mg/1 Details

Azo Urinary Tract Defense 162; 162.5 mg/1; mg/1

Azo Urinary Tract Defense is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by i-Health, Inc.. The primary component is METHENAMINE; SODIUM SALICYLATE.

Product Information

NDC	49973-0011
Product ID	49973-011_974312f7-a247-449d-978a-831de0f9bc83
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Azo Urinary Tract Defense
Proprietary Name Suffix	Antibacterial Protection
Non-Proprietary Name	Methenamine, Sodium salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	162; 162.5
Active Ingredient Units	mg/1; mg/1
Substance Name	METHENAMINE; SODIUM SALICYLATE
Labeler Name	i-Health, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49973-0011-18 (49973001118)

Pricing Information	N/A
NDC Package Code	49973-011-18
Billing NDC	49973001118
Package	1 BLISTER PACK in 1 BOX (49973-011-18) / 18 TABLET in 1 BLISTER PACK
Marketing Start Date	2018-04-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba13a608-e4c5-4465-8be8-be0fd1fd46ae Details

Drug Facts

Active Ingredients (in each tablet):

Methenamine 162 mg

Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)

SPL UNCLASSIFIED SECTION

Purpose

Antibacterial

Analgesic (pain reliever)

SPL UNCLASSIFIED SECTION

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

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

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.

INGREDIENTS AND APPEARANCE

AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION

methenamine, sodium salicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49973-011
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV)	METHENAMINE	162 mg
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SODIUM SALICYLATE	162.5 mg

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZOUD
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49973-011-24	1 in 1 BOX	03/01/2016
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:49973-011-18	1 in 1 BOX	04/23/2018
2		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:49973-011-04	4 in 1 POUCH; Type 0: Not a Combination Product	11/06/2015	01/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/06/2015

Labeler - i-Health, Inc. (061427694)

Revised: 12/2020

Document Id: 974312f7-a247-449d-978a-831de0f9bc83

Set id: ba13a608-e4c5-4465-8be8-be0fd1fd46ae

Version: 5

Effective Time: 20201212

Search by Drug Name or NDC

NDC 49973-0011-18 Azo Urinary Tract Defense 162; 162.5 mg/1; mg/1 Details

Azo Urinary Tract Defense 162; 162.5 mg/1; mg/1

Product Information

Package

Package Images

NDC 49973-0011-18 (49973001118)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba13a608-e4c5-4465-8be8-be0fd1fd46ae Details

Drug Facts

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 49973-0011-18 Azo Urinary Tract Defense 162; 162.5 mg/1; mg/1 Details

Azo Urinary Tract Defense 162; 162.5 mg/1; mg/1

Product Information

Package

Package Images

NDC 49973-0011-18 (49973001118)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba13a608-e4c5-4465-8be8-be0fd1fd46ae Details

Drug Facts

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

﻿Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Warnings