AZO Urinary Pain Relief

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary analgesic

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

Warnings

Please read insert for important precautions.

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.

If pregnant or breastfeeding, ask a professional before 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.
Children under 12: Do not use without consulting a doctor
Do not use for more than 2 days (12 tablets) 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 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.

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

Distributed by i-Health, Inc.

55 Sebethe Drive, Cromwell, CT 06416

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

www.azoproducts.com

Fast Relief for Urinary Pain

AZO

Urinary Pain Relief

VALUE SIZE

NOT A COMMON PAIN RELIEVER

Relieves Pain, Burning and Urgency

TARGETS THE SOURCE OF PAIN

Number 1 PHARMACIST RECOMMENDED

30 Tablets
95 mg Phenazopyridine Hydrochloride

Pain Burning Urgency

Number 1 Urinary Pain Reliever

Fast Relief for Urinary Pain

Informacion y instrucciones en Espanol adjuntas

AZO Urinary Pain Relief
STANDARD

Phenazopyridine Hydrochloride 95mg 30 Tablets

AZO
urinary pain relief tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49973-301
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Phenazopyridine Hydrochloride (Phenazopyridine )	Phenazopyridine Hydrochloride	95 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSES
POVIDONE
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOLS
CARNAUBA WAX
MAGNESIUM STEARATE

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

#	Item Code	Package Description
Packaging
1	NDC:49973-301-31	15 in 1 BOX
1		2 in 1 BLISTER PACK
2	NDC:49973-301-30	15 in 1 BOX
2		2 in 1 CELLO PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/24/2012

Labeler - i-Health, Inc. (061427694)

Name	Address	ID/FEI	Business Operations
Establishment
Amneal Pharmaceuticals, Inc.		968119730	manufacture

Revised: 5/2012

Document Id: 1358e4b4-e2af-4893-abc1-243378791147

Set id: 3d0298b7-eaec-488b-9cab-19af4614ff53

Version: 1

Effective Time: 20120524

i-Health, Inc.