URISTAT ULTRA- phenazopyridine hydrochloride tablet 
Medtech Products 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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Uristat Ultra

URISTAT ® ULTRA

Phenazopyridine Hydrochloride  99.5 mg

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine hydrochloride 99.5 mg

Purpose

Urinary analgesic

Use

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

Warnings

Do not exceed recommended dosage

Ask a doctor before use if you have

  • kidney disease 
  • allergies to foods, preservatives, or dyes
  • had a hypersensitive reaction to phenazopyridine

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 breast-feeding,

ask a health care professional before use. 

Keep out of reach of children.

In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

Other information

Inactive ingredients

citric acid, artificial & natural cranberry flavor, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica, starch, and sucralose.

 Questions?

1-800-344-7239  Uristat.com

PRINCIPAL DISPLAY PANEL

URISTAT® ULTRA with Cranberry flavored coating

UTI Pain Relief Tablets

Phenazopyridine Hydrochloride  99.5 mg

30 Urinary Pain Relief Tablets

PRINCIPAL DISPLAY PANEL
URISTAT® ULTRA with Cranberry flavored coating
UTI Pain Relief Tablets
Phenazopyridine Hydrochloride  99.5 mg
30 Urinary Pain Relief Tablets

RISTAT® ULTRA with Cranberry flavored coating

UTI Relief PAK™

Phenazopyridine Hydrochloride  99.5 mg

1 UTI Test Strip and 12 Urinary Pain Relief Tablets

RISTAT® ULTRA with Cranberry flavored coating
UTI Relief PAK™
Phenazopyridine Hydrochloride  99.5 mg
1 UTI Test Strip and 12 Urinary Pain Relief Tablets

URISTAT ULTRA 
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize7mm
FlavorCRANBERRYImprint Code X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-105-121 in 1 CARTON02/15/2018
112 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
2NDC:63029-105-303 in 1 CARTON02/15/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/15/2018
Labeler - Medtech Products Inc. (122715688)

Revised: 2/2019
Document Id: 3a9d3614-0903-46af-8b81-a411ef852100
Set id: c705185f-4908-451e-993b-b0b8a73f0392
Version: 2
Effective Time: 20190214
 
Medtech Products Inc.