Cystex Tablet
FDA Label NDC 69693-518

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clarion Brands, Llc for the product Cystex (NDC 69693-518). 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 ingredients, purposes, uses, warnings, do not use, ask a doctor before use if you are, 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.

Label Section Quick Index

Active Ingredients

Methenamine 162 mg Antibacterial
Sodium Salicylate 162.5 mg (NSAID*) *nonsteroidal anti-inflammatory drug.....Analgesic (pain reliever)

Purposes

Antibacterial

Uses

temporarily relieves pain, 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. 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 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

  • if you are allergic to salicylates (including aspirin)

Ask A Doctor Before Use If You Are

  • 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
  • reach 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

  • ringing in the ears
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain or upset that gets worse or lasts

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding ask a health professional before use.  It is especially important not to use this product (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. 

Otc - 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.

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.

    • Children under 12 years:

    • ask a doctor.

      • Do not use for more than a 3 day period unless directed by a doctor.

Other Information

  • each tablet contains: sodium 24.4 mg
  • store at 59-86°F (15-30°C) in a cool dry place 
  • protect from sunlight

Inactive Ingredients

benzoic acid, cellulose, croscarmellose sodium, edible black ink, fd&c red #40 lake, fd&c yellow #6 lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium Stearate, methacrylic acid-ethyl acrylate copolymer, silica, stearic acid, titanium dioxide, Triethyl citrate

Principal Display Panel

DUAL ACTION

Cystex®
Urinary Health

Methenamine 162 mg | Sodium Salicylate 162.5 mg (NSAID)

PAIN RELIEF (NSAID)

+ UTI BACTERIA CONTROL

2-in-1 Formula to Help Slow UTI Bacteria
Growth and Provice General Pain Relief

Helps Control
UTI infection

Formulated for no
Urine Discoloration

#1 Ingredient for UTI BACTERIAL
Control* 

Cystex is not intended to replace a doctor's care.

24 Tablets

TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.

Distributed by: Cystex, LLC 811 Broad Street
Suite 600, Chattanooga, TN 37402 ©2024
Call 844-297-8394 or visit Cystex.com

*Source: IRI Sales Data, 2023.

Does not contain urine coloring agents as
found in other leading UTI products

1000288
Made In India
RA/Drug/RAJ.-1750

48 tablets

1000273

* Please review the disclaimer below.