URISTAT UTI RELIEF PAK- phenazopyridine hydrochloride tablet

Uristat by

Drug Labeling and Warnings

Uristat by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

URISTAT ®

Relief PAK ™

with test strip and tablets

1 UTI Test Strip 

12 Pain Relief Tablets

Phenazopyridine Hydrochloride 95mg

Step 1: Test for infection

Step 2: Temporarily relieve your pain with URISTAT ® pain relief tablets

URISTAT ® Relief PAK™ can help detect if you have a urinary tract infection (UTI). URISTAT® Relief PAK™ uses the same science most doctors use.

Directions: Simply wet test strip by holding it in your urine stream for 1-2 seconds. Read result at 1 minute for Nitrate and at 2 minutes for Leukocytes. Match the color of the strip pads to the color blocks on the foil pouch. See insert inside box for complete instructions.

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 you 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

• Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.
  
• Children under 12 years of age: consult a doctor.

Do not use for more than 2 days (12 tablets) without consulting a doctor

Other information

• This product may stain contact lenses
  
• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
  
• Long term administration of phenazopyridine HCL has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
  
• Store at 20º-25º C (68º-77º F) in a dry place and protect from light.

Inactive ingredients

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

Questions?

1-800-344-7239 Uristat.com

©2015 Distributed by:

Insight Pharmaceuticals LLC

Tarrytown, NY 10591

A Prestige Brands Company

PRINCIPAL DISPLAY PANEL

URISTAT ®

UTI Relief PAK™

with test strip and tablets

1 UTI Test Strip & 12 Pain Relief Tablets
Phenazopyridine Hydrochloride 95 mg

INGREDIENTS AND APPEARANCE

URISTAT  UTI RELIEF PAK
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-961
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	95 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	U
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-961-12	1 in 1 CARTON	04/29/2015
1		12 in 1 CARTON; Type 1: Convenience Kit of Co-Package
2	NDC: 63736-961-01	36 in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		04/29/2015

Labeler - Insight Pharmaceuticals LLC (055665422)