AZO Urinary Tract Health

AZO URINARY TRACT HEALTH- phenazopyridine hydrochloride 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.

Active Ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 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 lactose

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

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

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

2 Solutions for Urinary Tract Health*

AZO

Urinary Tract Health

SUPPORT PACK

Urinary Pain Relief

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

MOST TRUSED #1 BRAND

18 Tablets

95 mg Phenazopyridine Hydrochloride

Cranberry

  • HELPS FLUSH TO MAINTAIN URINARY TRACT CLEANLINESS*
  • WITH PROBIOTIC

14 Caplets

Dietary Supplement

*THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA. THIS IF NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

Label 12
(click image for full-size original)

Label 24
(click image for full-size original)

Label 30
(click image for full-size original)

Support Pack
(click image for full-size original)

AZO URINARY TRACT HEALTH
phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49973-760
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A CORN
TALC
Product Characteristics
Color brown (Maroon) Score no score
Shape ROUND (Tablet) Size 7mm
Flavor Imprint Code W
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49973-760-32 9 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 2 TABLET in 1 BLISTER PACK This package is contained within the BOX (49973-760-32)
2 NDC:49973-760-30 15 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 2 TABLET in 1 BLISTER PACK This package is contained within the PACKAGE (49973-760-30)
3 NDC:49973-760-24 12 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
3 2 TABLET in 1 BLISTER PACK This package is contained within the PACKAGE (49973-760-24)
4 NDC:49973-760-12 6 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
4 2 TABLET in 1 BLISTER PACK This package is contained within the PACKAGE (49973-760-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/28/2014
Labeler — i-Health, Inc. (061427694)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corporation 057795122 manufacture (49973-760)

Revised: 01/2019 i-Health, Inc.

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