All-In-One UTI Emergency Kit

Manufacturer
UQORA INC | Pharbest
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:21

Label at a glance#

ProductAll-In-One UTI Emergency Kit
Active ingredientMETHENAMINE, SODIUM SALICYLATE, PHENAZOPYRIDINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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. 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 consultin...

Storage and handling

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 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 f...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

UTI Infection Control

SPL UNCLASSIFIED SECTION

Temporarily relieves:

  • pain and burning
  • frequency and urgency of urination

UTI Pain Relief

SPL UNCLASSIFIED SECTION

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

Warnings

WARNINGS SECTION

Reye's Syndrome (UTI Infection Control Only)

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage

Do Not Use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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)

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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)

SPL UNCLASSIFIED SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

UTI Infection Control

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Keep Out Of The Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

UTI Infection Control

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

UTI Infection Control

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

UTI Infection Control

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

uqora

Urinary Care

Maximum Strength UTI Pain Relief Included

ALL-IN-ONE

UTI EMERGENCY KIT

2 Day Supply Includes:

Test Strips

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

Infection Control

  • Helps slow infection progression until you're able to see a doctor
  • 12 Tablets (Methenamine & Sodium Salicylate (NSAID)

Max Strength Pain Relief

  • Max strength relief to quickly soothe UTI pain & burning
  • 12 Tablets (99.5mg Phenazopyridine Hydrochloride)

Packaged for convenience. Not intended to replace medical care.

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73712-113ALL-IN-ONE UTI EMERGENCY KIT (METHENAMINE, SODIUM SALICYLATE, AND PHENAZOPYRIDINE HYDROCHLORIDE) KIT [UQORA INC]2Legacy NDC20241219_ebde96d2-e1f2-26b1-e053-2a95a90a2fb1.zip
73712-500ALL-IN-ONE UTI EMERGENCY KIT (METHENAMINE, SODIUM SALICYLATE, AND PHENAZOPYRIDINE HYDROCHLORIDE) KIT [UQORA INC]2Legacy NDC20241219_ebde96d2-e1f2-26b1-e053-2a95a90a2fb1.zip
73712-804ALL-IN-ONE UTI EMERGENCY KIT (METHENAMINE, SODIUM SALICYLATE, AND PHENAZOPYRIDINE HYDROCHLORIDE) KIT [UQORA INC]2Legacy NDC20241219_ebde96d2-e1f2-26b1-e053-2a95a90a2fb1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73712-50073712-500-24
73712-80473712-804-12
73712-11373712-113-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All-In-One UTI Emergency KitMETHENAMINE, SODIUM SALICYLATE, AND PHENAZOPYRIDINE HYDROCHLORIDEBonafide Health, LLC dba Uqora434652a1-583e-d6f7-e063-6394a90aab8a2025-11-10WarningsExact identifier
ndc (package): 73712-804-12
ndc11 (package): 73712080412
4346cb9f-3541-3c6b-e063-6294a90ad78cebde96d2-e1f2-26b1-e053-2a95a90a2fb12025-11-10WarningsExact identifier
spl set id: ebde96d2-e1f2-26b1-e053-2a95a90a2fb1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.