Label: ALL-IN-ONE UTI EMERGENCY KIT- methenamine, sodium salicylate, and phenazopyridine hydrochloride kit

  • NDC Code(s): 73712-113-12, 73712-500-24, 73712-804-12
  • Packager: UQORA INC
  • 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 October 17, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Methenamine 162mgAntibacterial

    Sodium Salicylate 162.5mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Analgesic (pain reliever)

    Active ingredient (in each tablet)

    Purpose
    Phenazopyridine Hydrochloride 99.5mgUrinary Tract Analgesic

  • Uses

    UTI Infection Control

    Temporarily relieves:

    • pain and burning
    • frequency and urgency of urination

    UTI Pain Relief

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

  • Warnings

    Reye's Syndrome (UTI Infection Control Only)

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this
    product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Stomach Bleeding Warning (UTI Infection Control Only)

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you

    • are 60 or older
    • have stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Do Not Exceed (UTI Pain Relief Only)

    Do not exceed recommended dosage

    Do Not Use

    Do not use:

    • If you are allergic to salicylates (including aspirin) ( UTI Infection Control only)
    • If you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your doctor ( UTI Pain Relief only)

    Ask A Doctor Before Use

    Ask a doctor before use if you have:

    • frequent, burning urination for the first time (UTI Infection Control only)
    • the stomach bleeding warning applying to you (UTI Infection Control only)
    • history of stomach problems, such as heartburn (UTI Infection Control only)
    • high blood pressure (UTI Infection Control only)
    • heart disease (UTI Infection Control only)
    • liver cirrhosis (UTI Infection Control only)
    • bleeding problems (UTI Infection Control only)
    • diuretic use (UTI Infection Control only)
    • ulcers (UTI Infection Control only)
    • kidney disease
    • a sodium restricted diect (UTI Infection Control only)
    • reached age 60 or older (UTI Infection Control only)
    • allergies to foods, preservatives or dyes (UTI Pain Relief only)
    • had a hypersensitive reaction to phenazopyridine (UTI Pain Relief only)

    Ask A Doctor Or Pharmacist Before Use (UTI Infection Control Only)

    Ask a doctor or pharmacist before use if you are:

    • taking any other drug containing an NSAID (prescription or non-prescription)
    • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug

    When Using This Product

    When using this product:

    • do not take more than the recommended dosage (UTI Infection Control only)
    • stomach upset may occur, taking this product with or after meals may reduce stomach upset (UTI Pain Relief only)
    • your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. (UTI Pain Relief only)

    Stop Use And Ask A Doctor

    Stop use and ask a doctor if:

    • product has been used for 3 days (UTI Infection Control only)
    • ringing in the ears (UTI Infection Control only)
    • you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stool ■ have stomach pain or upset that gets worse or lasts (UTI Infection Control only)
    • your symptoms last for more than 2 days (UTI Pain Relief only)
    • you suspect you are having an adverse reaction to the medication (UTI Pain Relief only)

    Long Term Administration (UTI Pain Relief Only)

    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.

    If Pregnant or Breast Feeding


    UTI Infection Control

    If pregnant or breast feeding, ask a health professional before use. It is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    UTI Pain Relief

    If pregnant or breast feeding, ask a health professional before use.

    Keep Out Of The Reach Of Children

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222

  • Directions

    UTI Infection Control

    Adults and children 12 years and over:

    • take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids.
    • Do not use for more than a 3 day period unless directed by a doctor.
    Children under 12 years: ask a doctor.

    UTI Pain Relief

    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
    • Do not use for more than 2 days (12 tablets) without consulting a doctor.
    Children under 12 years: consult a doctor
  • Other Information

    UTI Infection Control

    • each tablet contains: sodium 24.4 mg
    • store at 59-86°F (15-30°C) in a cool dry place
    • protect from sunlight
    • Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged

    UTI Pain Relief

    • this product may stain contact lenses
    • this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
    • store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light
    • Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged
  • Inactive Ingredients

    UTI Infection Control

    benzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

    UTI Pain Relief

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

  • QUESTIONS

    Distributed by Uqora, Inc.

    3043 4th Avenue, San Diego, CA 92103

    support@uqora.com

    For questions or concerns please contact (888) 313-1372

  • Additional Items

    2 diagnostic UTI test strips (Directions Enclosed)

    Other information

    • store at room temperature 59-86 F (15-30 C) out of direct sunlight. Do not refrigerate or freeze
    • For in-vitro (external) diagnostic use.
  • Principal Display Panel

    uqora

    Urinary Care

    3-in-1 Convenience Kit

    ALL-IN-ONE

    UTI EMERGENCY KIT

    2 Day Supply Includes:

    Test Strips

    • Test for a possible UTI at home in 2 minutes
    • 2 Tests

    Infection Control

    • Help manage a UTI & slow infection progress
    • 12 Tablets (Methenamine & Sodium Salicylate (NSAID)

    Pain Relief

    • Quickly sooth UTI pain & burning to feel relief
    • 12 Tablets (99.5mg Phenazopyridine Hydrochloride)

    Packaged for convenience. Not intended to replace medical care.

    Emergency Kit Carton

  • INGREDIENTS AND APPEARANCE
    ALL-IN-ONE UTI EMERGENCY KIT 
    methenamine, sodium salicylate, and phenazopyridine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73712-500
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73712-500-241 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)10/17/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK 12 
    Part 1 of 2
    UQORA ANTIBACTERIAL PLUS URINARY PAIN RELIEF 
    methenamine, sodium salicylate tablet
    Product Information
    Item Code (Source)NDC:73712-804
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE162 mg
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE162.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73712-804-1212 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/17/2022
    Part 2 of 2
    UQORA MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Item Code (Source)NDC:73712-113
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code p99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73712-113-1212 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/17/2022
    Labeler - UQORA INC (022730893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture(73712-500)