Label: MAXIMUM STRENGTH URINARY PAIN RELIEF- 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 February 2, 2023

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

  • Drug Facts

  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 99.5 mg 

  • Purpose

    Urinary tract analgesic

  • Use

    Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

  • Warnings

    Do not exceed recommended dosage

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

    Ask a doctor before use if you have         • kidney disease
    • allergies to foods, preservatives or dyes   • had a hypersensitive reaction to Phenazopyridine Hydrochloride

    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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

    If pregnant or breastfeeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. 

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

  • Directions

    Adults and children 12 years and over: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor • Children under 12 years: Do not use without consulting a doctor

  • Other information

    • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests • This product may stain contact lenses and other items if handled after touching tablets. • Store at room temperature between 20ºC -25ºC (68ºF -77ºF) in a dry place and protect from light.

  • Inactive ingredients

    colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.

  • Questions?

    1-800-910-6874

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient in AZO® Urinary Pain Relief Maximum Strength*  

    maximum strength UTI pain reliever available without a prescription

    up&up

    Among our over-the-counter urinary pain relief products

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    245 03 0248   R01  C-002016-01-009
    Dist. by Target Corp., Mpls., MN 55403
    Product of India TM & ©2023 Target Brands, Inc.

    *This product is not manufactured or distributed by i-Health Inc., distributor of AZO® Urinary Pain Relief

    WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more Information, visit www.P65Warnings.ca.gov

  • Packaging

    TargetCorp1

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-270
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACACIA (UNII: 5C5403N26O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    Colorbrown (Dark Brown) Scoreno score
    ShapeRECTANGLESize9mm
    FlavorImprint Code S160
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-270-241 in 1 CARTON01/25/2023
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/25/2023
    Labeler - TARGET CORPORATION (006961700)