Label: PREFERRED MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • NDC Code(s): 10956-210-12, 10956-210-24
  • Packager: Reese Pharmaceutical Co
  • 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 29, 2022

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

View All Sections
  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 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

  • 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

    Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, 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
    PREFERRED MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-210
    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
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code p99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-210-121 in 1 CARTON07/31/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:10956-210-241 in 1 CARTON07/31/2019
    224 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2019
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!