Active Ingredient (In Each Tablet) - (Uti Infection Control Only)
Methenamine 162 mg
Sodium Salicylate 162.5 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Uti Emergency Relief Kit
FDA Label NDC 73436-4882
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cadence Health, Inc. for the product Uti Emergency Relief (NDC 73436-4882). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet) - (uti infection control only), purpose - (uti infection control only), active ingredient (in each tablet) - (uti pain relief only), purpose - (uti pain relief only), uses, warnings, do not use:, ask a doctor before use if you have:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose - (Uti Infection Control Only)
Antibacterial
Analgesic (pain reliever)
Active Ingredient (In Each Tablet) - (Uti Pain Relief Only)
Phenazopyridine Hydrochloride 99.5mg
Purpose - (Uti Pain Relief Only)
Urinary 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:This product contains a non-steroidal 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:
- 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 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 diet (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 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:
- 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 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 Breastfeeding
UTI Infection Control
If pregnant or breastfeeding,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 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.
- 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:ask a doctor.
UTI Pain Relief
Adults and children 12 years and over:
Children under 12 years: ask a doctor.
Other Information 1
UTI Infection Control
- each tablet contains:sodium 24.4 mg
- store at 59-86°F (15-30°C) in a 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 from light
- Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged
UTI Pain Relief
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.
Manufactured For
Cadence OTC, Oakland, CA 94612
Questions Or Comments:
Call 1-877-862-7455 or visit us at cadenceotc.com
Additional Items
2 diagnostic UTI test strips(Directions Enclosed)
Other Information 2
- 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
Max Strength Pain Relief ■ Bacteria Control
Cadence
OTC
UTI
EMERGENCY
RELIEF™
| 2 UTI Test Strips | Quick and easy
UTI test |
| 12 Pain Relief Tablets 99.5 MG PHENAZOPYRIDINE HYDRACHLORIDE | Maximum strength,
fast relief from UTI pain and burning |
| 12 Infection Control Tablets METHENAMINE AND SODIUM SALICYLATE (NSAID) | Antibacterial to help
control a UTI |
PACKAGED FOR CONVENIENCE. NOT INTENDED TO REPLACE MEDICAL CARE.
| Cadence OTC's UTI Emergency Relief™ |
|
EKITCAD Rev 12/25
Carton (Carton)
* Please review the disclaimer below.
