Cystex Tablet
FDA Label NDC 69693-512

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 69693-512). 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 (in each tablet):, purpose, indications & usage, warnings, do not use, ask a doctor before use if, 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 (In Each Tablet):

Methenamine 162 mg
Sodium Salicylate 162.5 mg (NSAID)*

*nonsteroidal anti-inflammatory drug
 

Purpose

Methenamine............Antibacterial
Sodium Salicylate.....Analgesic (pain reliever)

Indications & Usage

Use 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 thinner (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 have frequent, burning urination for the first time
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking any other drug containing an NSAID (prescription or non prescription)
  • taking a prescription drug for anticoagulation (blood thinning), gout, diabetes, or arthritis

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 occurs
  • 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.

Keep Out Of 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 overtake 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids
children under 12 yearsask a doctor

Other Information

  • store at 59-86° F (15-30° C) in a dry place
  • protect from light
  • each tablet contains: 23.7 mg sodium

Questions?

Call 1-844-297-8394

Inactive Ingredients

benzoic acid, cellulose, croscarmellose sodium, edible blank 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

FAST RESULTS!

Relieves pain & burning
Plus helps control infection*

CYSTEX® PLUS
Urinary Pain Relief Tablets
(NSAID)

The ONLY brand that provides pain relief plus antibacterial protection*

*Only Cystex tablets help inhibit the progression of infection until you see the doctor. Cystex is not intended to replace a doctor's care

40 TABLETS

Guaranteed Satisfaction. If you are not completely satisfied, send us a copy of your cash register receipt, UPC code # along with your full name and address and we will replace or refund your purchase. Limit one refund per household.

USE ONLY IF BLISTER UNIT IS UNBROKEN

If you have any questions or difficulties finding this product, please go to our website: www.cystex.com

Distributed by: Clarion Brands, LLC
27070 Miles Road, Suite A, Solon, OH 44139       3004A      ©2015

CYSTEX
URINARY PAIN RELIEF TABLETS

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 age 60 or older ▅ have stomach ulcers or bleeding problems ▅ take a blood thinner (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

ATTENTION: USE ONLY IF TABLET BLISTER SEALS ARE UNBROKEN

CLARION BRANDS, LLC. 1-844-297-8394      5003 

* Please review the disclaimer below.