AZO- urinary pain relief tablet

AZO by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 mg

PURPOSE

Purpose

Urinary tract analgesic

INDICATIONS & USAGE

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

WARNINGS

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.

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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.

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

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

DOSAGE & ADMINISTRATION

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.
• Children under 12: Do not use without consulting a doctor
• Do not use for more than 2 days (12 tablets) without consulting a doctor.
  

GENERAL PRECAUTIONS

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 F) in a dry place and protect from light
• Tamper evident: tablets sealed in blisters.  Do not use if blister foil or seal is open or damaged.
• Carcinogenesis: Long-term administration of Phenazopyridine Hydrochloride has induced neoplasia in rats (large intestine) and mice (liver).  Although no association between Phenazopyridine Hcl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

INACTIVE INGREDIENT

Inactive ingredients microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate.  May also contain corn starch.

QUESTIONS

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

Made in India.

ϯNeilsen data through January 26, 2013.

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

www.azoproducts.com

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

AZO 
urinary pain relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49973-244
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MAGNESIUM STEARATE (UNII: 70097M6I30)

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: 49973-244-12	6 in 1 BOX	05/18/2012
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49973-244-24	12 in 1 BOX	05/18/2012
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 49973-244-02	2 in 1 POUCH; Type 0: Not a Combination Product	12/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/18/2012

Labeler - i-Health, Inc. (061427694)