AZO Urinary Pain Relief Maximum Strength

AZO by

Drug Labeling and Warnings

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

Drug Details [pdf]

AZO- urinary pain relief 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 Pain Relief Maximum Strength

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 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 glucose

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 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 or 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 sealed within blisters.  Do not use if blister foil or seal is torn, open or damaged.

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

Distributed by i-Health, Inc. 55 Sebethe Drive, Cromwell, CT 06416

Country of Origin: U.S.

Size and color of tablets may vary.

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

Fast Effective Pain Relief

AZO

Urinary Pain Relief

MAXIMUM STRENGTH

• MORE ACTIVE INGREDIENT RELIEVES PAIN, BURNING & URGENCY
• TARGETS THE SOURCE OF PAIN

#1 MOST TRUSTED BRAND

Tablets

97.5 mg Phenazopyridine Hydrochloride

AZO 
urinary pain relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49973-245
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenazopyridine Hydrochloride (UNII: 0EWG668W17) (Phenazopyridine - UNII:K2J09EMJ52)	Phenazopyridine Hydrochloride	97.5 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	Score	no score
Shape	OVAL (Tablet)	Size	8mm
Flavor		Imprint Code	WX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49973-245-12	6 in 1 BOX	03/04/2014	02/01/2017
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49973-245-24	12 in 1 BOX	03/04/2014	02/01/2017
2		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		03/04/2014	02/01/2017

Labeler - i-Health, Inc. (061427694)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		057795122	manufacture(49973-245)

Revised: 12/2019

Document Id: e8285f53-b531-4760-89c3-6483146034a0

34390-5

Set id: 2cf863e1-cd38-47a9-8c52-3dac465e9034

Version: 3

Effective Time: 20191226

 

i-Health, Inc.