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AZO Urinary Pain Relief


Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg


OTC - PURPOSE SECTION

Purpose

Urinary analgesic


INDICATIONS & USAGE SECTION

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


WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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


OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask doctor 

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


DOSAGE & ADMINISTRATION SECTION

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.

GENERAL PRECAUTIONS SECTION

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 INGREDIENT SECTION

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


OTC - QUESTIONS SECTION

Distributed by i-Health, Inc.

55 Sebethe Drive, Cromwell, CT 06416

Made in India.

Most Trusted Brand based on Nielsen data through 3/23/2013.

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

www.azoproducts.com


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AZO  

Urinary Pain Relief 

#1 Most Trusted Brand

Tablets

95 mg Phenazopyridine Hydrochloride

  • Relieves pain, burning & urgency
  • Targets the source of pain