Label: URO-PAIN- phenazopyridine hydrochloride tablet

  • NDC Code(s): 57237-331-03
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 14, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 95 mg

  • PURPOSE

    Purpose

    Urinary tract analgesic

  • INDICATIONS & USAGE

    Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

  • WARNINGS

    Warnings

    Ask a doctor before use if you have

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

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

    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 breastfeeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years and older: 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: Do not use without consulting a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients  carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

  • OTHER SAFETY INFORMATION

    Other Information

    • 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 (59o-86oF) 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.

  • SPL UNCLASSIFIED SECTION

    Questions or comments? Call 1-844-474-7464

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816
    Made in India
    Mfg License Code:
    RA/Drug/RAJ.-1750

    Issued: 09/2023

  • Packaging

    NDC 57237-331-03

    URO-PAINTM

    Phenazopyridine Hydrochloride Tablets, 95 mg

    Urinary Tract Pain Relief

    • Relieves Pain, Burning and Urgency
    • Targets the source of Pain
    Phenazopyridine-lable
  • INGREDIENTS AND APPEARANCE
    URO-PAIN 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-331
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorred (Maroon) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code p
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-331-031 in 1 CARTON12/06/2023
    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 other12/06/2023
    Labeler - Rising Pharma Holdings, Inc. (116880195)
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