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AZO Urinary Tract Health: Package Insert / Prescribing Info

Package insert / product label
Generic name: phenazopyridine hydrochloride
Dosage form: tablet
Drug class: Miscellaneous genitourinary tract agents

Medically reviewed by Drugs.com. Last updated on Jun 17, 2024.

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

Label 24

Label 30

Support Pack

AZO URINARY TRACT HEALTH
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49973-760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)
Product Characteristics
Colorbrown (Maroon) Scoreno score
ShapeROUND (Tablet) Size7mm
FlavorImprint CodeW
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49973-760-329 in 1 BOX02/28/2014
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49973-760-3015 in 1 PACKAGE02/28/2014
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:49973-760-2412 in 1 PACKAGE02/28/2014
32 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:49973-760-126 in 1 PACKAGE02/28/2014
42 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/28/2014
Labeler - i-Health, Inc. (061427694)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122manufacture(49973-760)

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