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

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary 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

Caution: Do not use this product 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 

  • 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.

Directions

Other Information

Inactive ingredientsmicrocrystalline 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.

Most Trusted Brand based on Nielsen data through 3/23/2013.

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

AZO  

Urinary Pain Relief 

#1 Most Trusted Brand

Tablets

95 mg Phenazopyridine Hydrochloride

AZO UPR Label Combined

AZO UPR 95

AZO 
urinary pain relief tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49973-301
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorbrown (Maroon) Scoreno score
ShapeROUND (Tablet) Size7mm
FlavorImprint Code W
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49973-301-3115 in 1 BOX05/24/2012
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49973-301-3015 in 1 BOX05/24/201212/01/2020
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:49973-301-321 in 1 BOX11/11/201711/30/2020
318 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/24/2012
Labeler - i-Health, Inc. (061427694)

Revised: 12/2020
Document Id: 9ff96c23-b19f-4664-abb3-359fb901d19b
Set id: 3d0298b7-eaec-488b-9cab-19af4614ff53
Version: 7
Effective Time: 20201212
 
i-Health, Inc.