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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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 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.
- Directions
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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
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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
- QUESTIONS
- Additional Items
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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.
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INGREDIENTS AND APPEARANCE
ALL-IN-ONE UTI EMERGENCY KIT
methenamine, sodium salicylate, and phenazopyridine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73712-500 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73712-500-24 1 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 Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 12 Part 1 of 2 UQORA ANTIBACTERIAL PLUS URINARY PAIN RELIEF
methenamine, sodium salicylate tabletProduct Information Item Code (Source) NDC:73712-804 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE 162 mg SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE 162.5 mg Inactive Ingredients Ingredient Name Strength 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 Color red Score no score Shape ROUND Size 11mm Flavor Imprint Code PH061 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73712-804-12 12 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/17/2022 Part 2 of 2 UQORA MAXIMUM STRENGTH URINARY PAIN RELIEF
phenazopyridine hydrochloride tabletProduct Information Item Code (Source) NDC:73712-113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Inactive Ingredients Ingredient Name Strength 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 Color brown Score no score Shape OVAL Size 9mm Flavor Imprint Code p99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73712-113-12 12 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/17/2022 Labeler - UQORA INC (022730893) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(73712-500)