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AZO Urinary Pain Relief Maximum Strength

Medically reviewed on February 9, 2018

Dosage form: tablet
Ingredients: PHENAZOPYRIDINE HYDROCHLORIDE 97.5mg
Labeler: i-Health, Inc.
NDC Code: 49973-246

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

Drug Facts

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

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

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 a 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°F) in a dry place and protect from light

Tamper evident: Product is sealed within blisters.  Do no use if any part of the blister is torn, open, or damaged. 

Inactive ingredients: Corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide and talc. 

Información y instrucciones en Español adjuntas

Distributed by i-Health, Inc.  55 Sebethe Drive, Cromwell, CT 06416

Made in India

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

From the #1 Brand

12 Tablets

97.5 mg Phenazopyridine Hydrochloride

AZO URINARY PAIN RELIEF  MAXIMUM STRENGTH
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
POVIDONE K30 
SILICON DIOXIDE 
TALC 
Product Characteristics
Colorbrown (red-brown) Scoreno score
ShapeOVALSize9mm
FlavorImprint CodeWX
Contains    
Packaging
#Item CodePackage Description
1NDC:49973-246-1212 BLISTER PACK in 1 BOX
12 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/09/2015
Labeler - i-Health, Inc. (061427694)

 
i-Health, Inc.

← See all AZO Urinary Pain Relief Maximum Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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