Label: QUALITY CHOICE URINARY PAIN RELIEF MAXIMUM STRENGTH- phenazopyridine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated January 16, 2019

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  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 97.5 mg .

  • Purpose

    Urinary Analgesic

  • Warnings

    Do not exceed recommended dosage

  • Ask doctor before use if you have

    ■ kidney disease
    ■ allergies to food, preservatives or dyes
    ■ had a hypersensitive reaction to phenazopyridine
    Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

  • 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 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 professional before use.

  • Keep out of reach of children

    In case of an overdose, get medical help or contact a Poison Control Center right away.

  • Use

    Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
    infections.

  • Inactive ingredients

    Corn Starch, Croscarmellose Sodium, hypromellose, Lactose,
    Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol,
    Polyvinylpyrrolidone, Pregelatinized Starch,
    Silicon Dioxide and Sodium Starch Glycolate.

  • Directions


    ■ adults and children 12 years and over:
    take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

    ■ children under 12 years: consult a doctor

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

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE URINARY PAIN RELIEF MAXIMUM STRENGTH 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-293
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code P97
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-293-242 in 1 CARTON03/31/2017
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/15/2015
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(63868-293) , repack(63868-293)