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AZO by i-Health, Inc.

Medically reviewed on March 5, 2018

Dosage form: tablet
Ingredients: Phenazopyridine Hydrochloride 97.5mg
Labeler: i-Health, Inc.
NDC Code: 49973-245

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.

AZO Urinary Pain Relief Maximum Strength

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 97.5 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 glucose

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.  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 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

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 sealed within blisters.  Do not use if blister foil or seal is torn, open or damaged.

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

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

Fast Effective Pain Relief

AZO

Urinary Pain Relief

MAXIMUM STRENGTH

  • MORE ACTIVE INGREDIENT RELIEVES PAIN, BURNING & URGENCY
  • TARGETS THE SOURCE OF PAIN

#1 MOST TRUSTED BRAND

Tablets

97.5 mg Phenazopyridine Hydrochloride

AZO 
urinary pain relief tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-245
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenazopyridine Hydrochloride (Phenazopyridine ) Phenazopyridine Hydrochloride97.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TALC 
Product Characteristics
ColorbrownScoreno score
ShapeOVAL (Tablet) Size8mm
FlavorImprint CodeWX
Contains    
Packaging
#Item CodePackage Description
1NDC:49973-245-126 BLISTER PACK in 1 BOX
12 TABLET in 1 BLISTER PACK
2NDC:49973-245-2412 BLISTER PACK (BLISTER PACK) in 1 BOX
22 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/04/2014
Labeler - i-Health, Inc. (061427694)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122manufacture(49973-245)

 
i-Health, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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