Cystex

Manufacturer
Clarion Brands, LLC
Effective date
2025-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:54

Label at a glance#

ProductCystex
Active ingredientMETHENAMINE, SODIUM SALICYLATE
Label structure16 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Methenamine 162 mg
Sodium Salicylate 162.5 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
 

Purpose

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Usetemporarily relieves

  • pain & burning
  • frequency and urgency of urination

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • if you are allergic to salicylates (including aspirin)

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • do not take more than the recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 stools
    • have stomach pain or upset that gets worse or lasts

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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 titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-844-297-8394

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW Large Size!
Now 48 Tablets

MAX STRENGTH

Cystex® 
Methenamine 162 mg & Sodium Salicylate 162.5 mg (NSAID)

UTI PAIN RELIEF  (NSAID)

+ BACTERIA CONTROL

Fast relief of pain & burning
plus helps control UTI bacteria


Maximum Strength
#1 OTC Ingredient for UTI Bacteria Control* 


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

48 Tablets

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

REV 3/22 CSTX048BRI

MAX STRENGTH

Cystex ®
Urinary Health Made Easy™

For more information on Cystex tablets or
Urinary Tract Infections please visit
www.cystex.com or call 844-297-8394.
*Source: IRI Sales Data, 2022.


Distributed by: Cystex, LLC
27070 Miles Road, Suite A
Solon, OH 44139 ©2022

MAX STRENGTH

Cystex ®
Urinary Health Made Easy™

1000069

P16250
48ct.

carton
carton

CYSTEX
Methenamine 162 mg / Sodium Salicylate 162.5 mg (NSAID)
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

LOT:    X00X000           EXP:    MM/YY

CYSTEX, LLC. 1-844-297-8394

1000075

Blister Pack
Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489934CYSTEX PLUS 162 MG / 162.5 MG Oral TabletPSN4
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSN4
1489934methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet [Cystex]SBD4
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCD4
1489934Cystex (methenamine 162 MG / sodium salicylate 162.5 MG) Oral TabletSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-513-24Cystex1 in 1 CARTONTABLET14
69693-513-24Cystex24 in 1 BLISTER PACKTABLET244
69693-513-48Cystex1 in 1 CARTONTABLET14
69693-513-48Cystex48 in 1 BLISTER PACKTABLET484

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69693-51369693-513-24, 69693-513-48
69693-512

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cystex PlusMETHENAMINE, SODIUM SALICYLATEClarion Brands, LLC62200228-be42-1cda-9493-02bb491537c82026-01-14WarningsExact identifier
ndc (product): 69693-512
CystexMETHENAMINE, SODIUM SALICYLATEClarion Brands, LLC4fe33a01-90de-451e-8b54-d84304c842d92025-12-27WarningsExact identifier
ndc (package): 69693-513-24
ndc (package): 69693-513-48
ndc (product): 69693-513
ndc11 (package): 69693051348
ndc11 (package): 69693051324
spl id: 46f3cf47-73a9-167f-e063-6294a90a8b57
spl set id: 4fe33a01-90de-451e-8b54-d84304c842d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.