Label: RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC- 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 December 7, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Phenazopyridine Hydrochloride 95 mg

  • Purpose

    Urinary Analgesic

  • Uses

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

  • Warning

    Do not exceed recommended dosage

    Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

  • Ask Doctor before use if you have


    ■ kidney disease
    ■ allergies to foods, preservatives or dyes
    ■ had a hypersensitive reaction to Phenazopyridine

  • When using this product

    ■ 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  

    Long-term administration of phenazopyridine hydrochloride 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.

  • If pregnant or breast feeding

    ask a health professional before use.

  • Keep out of the reach of children

    in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.

  • 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

  • Other Information


    ■ this product may stain contact lenses
    ■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
    ■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light

  • Inactive Ingredients

    lactose, corn starch, croscarmellose sodium, microcrystalline

    cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, 

    pregelatinized starch, silicon dioxide, talc, and triacetin.

  • PRINCIPAL DISPLAY PANEL

    image of carton
  • INGREDIENTS AND APPEARANCE
    RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1411
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code P95
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1411-071 in 1 CARTON12/07/2023
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/07/2023
    Labeler - Rugby Laboratories (079246066)
    Registrant - Reese Pharmaceutical Co (004172052)