AZO- urinary pain relief 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.

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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.

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 doctor if

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

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

If pregnant or breastfeeding, as a professional before use.  A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. 

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.
  • Children under 12: Do not use without consulting a doctor
  • Do not use for more than 2 days (12 tablets) without consulting a doctor.

Other Inf ormation

  • 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.
  • Carcinogenesis: Long-term administration of Phenazopyridine Hydrochloride has induced neoplasia in rats (large intestine) and mice (liver).  Although no association between Phenazopyridine Hcl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

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

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

Made in India.

ϯNeilsen data through January 26, 2013.

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 24

Azo 12

Azo 2 Pouch

AZO 
urinary pain relief tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-244
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POVIDONE (UNII: FZ989GH94E)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorbrownScoreno score
ShapeOVAL (Tablet) Size8mm
FlavorImprint Code WX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49973-244-126 in 1 BOX05/18/2012
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49973-244-2412 in 1 BOX05/18/2012
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:49973-244-022 in 1 POUCH; Type 0: Not a Combination Product12/28/201710/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/18/201203/31/2021
Labeler - i-Health, Inc. (061427694)

Revised: 11/2021
 
i-Health, Inc.