URISTAT ULTRA- phenazopyridine hydrochloride tablet

Uristat Ultra by

Drug Labeling and Warnings

Uristat Ultra by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

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

RISTAT® ULTRA with Cranberry flavored coating

UTI Relief PAK™

Phenazopyridine Hydrochloride  99.5 mg

1 UTI Test Strip and 12 Urinary Pain Relief Tablets

INGREDIENTS AND APPEARANCE

URISTAT ULTRA 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	99.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN	Score	no score
Shape	ROUND	Size	7mm
Flavor	CRANBERRY	Imprint Code	X
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-105-12	1 in 1 CARTON	02/15/2018
1		12 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
2	NDC: 63029-105-30	3 in 1 CARTON	02/15/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/15/2018

Labeler - Medtech Products Inc. (122715688)