Label: URISTAT ULTRA- phenazopyridine hydrochloride tablet

  • NDC Code(s): 63029-105-12, 63029-105-30
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 14, 2019

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  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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)
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