AZO URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

AZO Urinary Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

PURPOSE

Purpose

Urinary tract analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings

Please read insert for important precautions.

ASK DOCTOR

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

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

WHEN USING

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

Stop use and ask a doctor if

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

PREGNANCY OR BREAST FEEDING

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

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredientsCorn starch, croscamellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide and talc.

QUESTIONS

Información y instrucciones en Español adjuntas

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

PRINCIPAL DISPLAY PANEL

Fast Relief for Urinary Pain

AZO

Urinary Pain Relief

VALUE SIZE

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

#1 MOST TRUSTED BRAND

30 Tablets

95 mg Phenazopyridine Hydrochloride

INGREDIENTS AND APPEARANCE

AZO URINARY PAIN RELIEF  
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49973-761
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: 49973-761-30	15 in 1 BOX	11/01/2014
1		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		11/01/2014

Labeler - i-Health, Inc. (061427694)