URISTATUTI RELIEF PAK UTI RELIEF PAK- phenazopyridine hydrochloride tablet 
Liberty Pharmaceuticals, 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

Drug Facts

Active ingredient

(in each tablet)

Phenazopyridine hydrochloride 95mg

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

corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, and talc

Questions?

Call 1-800-344-7239 or visit our website at www.Uristat.com

©2015 Distributed by:
Insight Pharmaceuticals LLC
Tarrytown, NY 10591
A Prestige Brands Company

Repackaged By:

Aidarex Pharmaceuticals, LLC.

Corona, CA 92882

PRINCIPAL DISPLAY PANEL

Phenazopyridine Hydrochloride 95mg

IMAGE LABEL
URISTATUTI RELIEF PAK  UTI RELIEF PAK
phenazopyridine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0440-8065(NDC:63736-961)
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
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize7mm
FlavorImprint Code U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0440-8065-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/29/2015
2NDC:0440-8065-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/29/2015
3NDC:0440-8065-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/29/2015
4NDC:0440-8065-6996 in 1 BLISTER PACK; Type 0: Not a Combination Product04/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/29/2015
Labeler - Liberty Pharmaceuticals, Inc. (012568840)

Revised: 10/2016
Document Id: 5a4f76e9-f914-4e6f-b218-abf3ab5460c6
Set id: f6e24576-e90c-451e-b2f8-261b61a00fcc
Version: 2
Effective Time: 20161012
 
Liberty Pharmaceuticals, Inc.