Label: MONISTAT MAINTAIN- phenazopyridine hydrochloride tablet

  • NDC Code(s): 63736-020-12
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 21, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

  • Purpose

    Phenazopyridine hydrochloride 99.5 mg………………………………………Urinary analgesic

  • Use

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

  • Warnings

    Do not exceed recommended dosage.

    Ask a doctor before use if you have

    • kidney disease
    • allergies to foods, 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 a doctor if

    • your symptoms last for more than 2 days
    • you suspect you are having an adverse reaction to the medication
    • experience a yellowish tinge of skin or eyes
    • experience fevers, chills, back pain or bloody urine

    If pregnant or breast feeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

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

  • Directions

    • Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.
    • Children under 12 years of age: 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 tests.
    • 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.
    • Store at 20º-25º C (68º-77º F) in a dry place and protect from light.
  • Inactive ingredients

    citric acid, artificial & natural cranberry flavor, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica, starch, and sucralose

  • Questions?

    1-877-666-4782 monistat.com

  • PRINCIPAL DISPLAY PANEL

    Maintain™ from the makers of Monistat® A Trusted Leader In Feminine Care (Logo)

    UTI

    2-in-1

    TEST + PAIN RELIEF KIT

    Phenazopyridine HCl 99.5 mg / Urinary analgesic

    with CRANBERRY FLAVORED COATING

    2 UTI Test Strips | 12 Urinary Pain Relief Tablets

    A box of pain relief AI-generated content may be incorrect.

  • INGREDIENTS AND APPEARANCE
    MONISTAT MAINTAIN 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-020
    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
    CITRIC ACID (UNII: 2968PHW8QP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize7mm
    FlavorCRANBERRYImprint Code X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-020-121 in 1 CARTON03/01/2025
    112 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2025
    Labeler - Insight Pharmaceuticals LLC (055665422)
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