Azo Urinary Tract Defense Antibacterial Protection (Methenamine, Sodium Salicylate) Tablet [I-Health, Inc.] -

AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]
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NDC	49973-011-04, 49973-011-18, 49973-011-24
Set ID	ba13a608-e4c5-4465-8be8-be0fd1fd46ae
Category	HUMAN OTC DRUG LABEL
Packager	i-Health, Inc.
Generic Name
Product Class
Product Number
Application Number

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Drug Facts

Active Ingredients (in each tablet):

Methenamine 162 mg

Sodium Salicylate 162.5 (NSAID Nonsteroidal Anti-Inflammatory Drug)
PURPOSE

Purpose

Antibacterial

Analgesic (pain reliever)
INDICATIONS & 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
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 & 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 SAFETY INFORMATION
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 INGREDIENT

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)

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Medic

AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]

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