URISTATUTI RELIEF PAK UTI RELIEF PAK (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [LIBERTY PHARMACEUTICALS, INC.]

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  • URISTATUTI RELIEF PAK UTI RELIEF PAK (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [LIBERTY PHARMACEUTICALS, INC.]

URISTATUTI RELIEF PAK UTI RELIEF PAK (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [LIBERTY PHARMACEUTICALS, INC.]
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NDC 0440-8065-01, 0440-8065-05, 0440-8065-30, 0440-8065-69
Set ID f6e24576-e90c-451e-b2f8-261b61a00fcc
Category HUMAN OTC DRUG LABEL
Packager Liberty Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    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

    • 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, 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

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    Phenazopyridine Hydrochloride 95mg

    IMAGE LABEL
  • INGREDIENTS AND APPEARANCE
    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)
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