Label: CYSTEX MAX UTI PAIN RELIEF- phenazopyridine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 22, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Phenazopyridine hydrochloride 99.5 mg

  • Purpose

    Urinary tract analgesic

  • INDICATIONS & USAGE

    Use fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days without consulting a doctor; see Directions.

  • Warnings

    • Do not exceed recommended dosage
    • 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.
  • Do not use

    if you have Glucose-6-Phosphare Dehydrogenase (G6PD) deficiency unless approved by your doctor

  • 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

    • do not exceed recommended dosage
    • 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.
    • do not use for more than 2 days (12 tablets) without consulting a doctor
  • 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use
    Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years of age and older: take 2 tablets 3 times a day with a full glass of water or after meals as needed

    • children under 12 years:
    • ask a doctor
  • Other information

    • WARNING: This product contains Phenazopyridine Hydrochloride, known to the state of California to cause cancer.
    • this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
    • this product may stain soft contact lenses and other items if handled after touching tablets
    • store at room temperature 59°F-86°F (15°C-30°C) in a dry place and protect from light

    Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

  • Inactive ingredients

    corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, triacetin

  • Questions

    call 1-844-297-8394

  • PRINCIPAL DISPLAY PANEL

    MAX STRENGTH

    Cystex®
    Urinary Health

    Phenazopyridine Hydrochloride 99.5 mg

    MAX UTI PAIN RELIEF

    FAST-ACTING UTI PAIN RELIEF

    Strongest UTI Pain Relief Available
    for Fast-Acting Relief of Pain & Burning*

    Relief of Pain, Burning, & Urgency

    √ Targets Pain at the Source of the UTI

    STARTS
    WORKING

    IN AS LITTLE AS 
    15 MINUTES

    Cystex is not intended to replace a doctor's care.

    24 Tablets

    TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.

    1000284

    REV XX/XX REESECODE

    For more information on
    Cystex Max Strength UTI Pain
    Relief or other products, please
    visit www.cystex.com or call
    844-297-8394

    Distributed by: Cystex LLC
    811 Broad Street, Suite 600
    Chattanooga, TN 37402  ©2024
    *without a prescription

    Carton
  • INGREDIENTS AND APPEARANCE
    CYSTEX MAX UTI PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-514
    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
    Starch, Corn (UNII: O8232NY3SJ)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Lactose, Unspecified Form (UNII: J2B2A4N98G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Starch Glycolate Type A (UNII: H8AV0SQX4D)  
    Talc (UNII: 7SEV7J4R1U)  
    Triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code CYSTEX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69693-514-241 in 1 CARTON08/02/2024
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/02/2024
    Labeler - Clarion Brands, LLC (079742703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(69693-514)