AZO Urinary Tract Health by i-Health, Inc. / Contract Pharmacal Corporation AZO Urinary Tract Health

AZO Urinary Tract Health by

Drug Labeling and Warnings

AZO Urinary Tract Health by is a Prescription medication manufactured, distributed, or labeled by i-Health, Inc., Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AZO URINARY TRACT HEALTH- phenazopyridine hydrochloride tablet 
i-Health, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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AZO Urinary Tract Health

Active Ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary tract analgesic

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Warnings

Please read insert for important precautions.

Ask a doctor before use if you have

• kidney disease
• allergies to foods, preservatives or dyes
• had a hypersensitive reaction to Phenazopyridine Hydrochloride
• Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
• sensitivities to lactose

When using this product

• stomach upset may occur, taking this product with or after meals may reduce stomach upset.
• your urine will become reddish-orange in color.  This is not harmful, but care should be taken to avoid staining clothing or other items.

Stop use and ask doctor if

• your symptoms last for more than 2 days
• you suspect you are having an adverse reaction to the medication.

If pregnant or breastfeeding, ask a health professional before use.  A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Keep out of reach of children.  In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days.  Take with a full glass of water.  Do not use for more than 2 days (12 tablets) without consulting a doctor.
• Children under 12: Do not use without consulting a doctor.

Other Information

• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
• This product may stain soft contact lenses and other items if handled after touching tablets
• Store at room temperature (59-86 degrees F) in a dry place and protect from light.

Tamper evident: Product is dealed within blisters.  Do not use if any part of the blister is torn, open or damaged.

Inactive ingredients  Lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, sodium starch glycolate and talc.

2 Solutions for Urinary Tract Health*

AZO

Urinary Tract Health

SUPPORT PACK

Urinary Pain Relief   

• RELIEVES PAIN, BURNING AND URGENCY
• TARGETS THE SOURCE OF PAIN

MOST TRUSED #1 BRAND

18 Tablets

95 mg Phenazopyridine Hydrochloride

Cranberry

• HELPS FLUSH TO MAINTAIN URINARY TRACT CLEANLINESS*
• WITH PROBIOTIC

14 Caplets

Dietary Supplement

*THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA.  THIS IF NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

AZO URINARY TRACT HEALTH 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49973-760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	95 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	brown (Maroon)	Score	no score
Shape	ROUND (Tablet)	Size	7mm
Flavor		Imprint Code	W
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49973-760-32	9 in 1 BOX	02/28/2014	11/30/2016
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49973-760-30	15 in 1 PACKAGE	02/28/2014	11/30/2016
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 49973-760-24	12 in 1 PACKAGE	02/28/2014	11/30/2016
3		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 49973-760-12	6 in 1 PACKAGE	02/28/2014	11/30/2016
4		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/28/2014	11/30/2016

Labeler - i-Health, Inc. (061427694)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		057795122	manufacture(49973-760)

Revised: 12/2019

Document Id: 7f13f7a6-69a2-444e-b31c-1c1a697df002

34391-3

Set id: 80ca7aae-55ed-42d7-9e6d-e89044d84577

Version: 5

Effective Time: 20191226

 

i-Health, Inc.