Uti Infection Control Tablet
FDA Label NDC 73436-1221

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 Infection Control (NDC 73436-1221). 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), purpose, uses, warnings, do not use:, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Methenamine 162 mg
Sodium Salicylate 162.5 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Antibacterial
Analgesic (pain reliever)

Uses

Temporarily relieves:

  • pain and burning
  • frequency and urgency of urination

Warnings

Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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 prescription or nonprescription NSAIDs (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:

if you are allergic to salicylates (including aspirin)

Ask A Doctor Before Use If You Have:

  • frequent, burning urination for the first time
  • the stomach bleeding warning applying to you
  • history of stomach problems, such as heartburn
  • high blood pressure
  • heart disease
  • liver cirrhosis
  • bleeding problems
  • diuretic use
  • ulcers
  • kidney disease
  • a sodium restricted diet
  • reached age 60 or older

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

Stop Use And Ask A Doctor If:

  • product has been used for 3 days
  • ringing in the ears
  • you experience any of the following signs of stomach bleeding: feel faint
  • vomit blood
  • have bloody or black stool
  • have stomach pain that gets worse or lasts

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.

Keep Out Of Reach Of Children

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

Directions

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.

Other Information

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

Inactive Ingredients

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

Manufactured For

Cadence OTC, Oakland, CA 94612

Questions Or Comments:

Call 1-877-862-7455 or visit us at cadenceotc.com

Package Label.Principal Display Panel

CadenceOTC

UTI
INFECTION
CONTROL

Antibacterial to help
control a UTI

METHENAMINE AND SODIUM SALICYLATE (NSAID)

2 day supply
12 tablets

NOT INTENDED TO REPLACE MEDICAL CARE.

CSDUALCAD
Rev 1/26

Carton (Carton)

Carton (Carton)

* Please review the disclaimer below.