CYSTEX- methenamine, sodium salicylate tablet 
Clarion Brands, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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)

Use temporarily relieves

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

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

Stop use and ask a doctor if

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. 

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

Adults and children 12 years and over:

Children under 12 years:

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

Other information

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 titanium dioxide, triethyl citrate

Questions or comments?

1-844-297-8394

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

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
CYSTEX 
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-513(NDC:69693-512)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methenamine (UNII: J50OIX95QV) (Methenamine - UNII:J50OIX95QV) Methenamine162 mg
Sodium Salicylate (UNII: WIQ1H85SYP) (Salicylic Acid - UNII:O414PZ4LPZ) Sodium Salicylate162.5 mg
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid (UNII: 8SKN0B0MIM)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Fd&c Red No. 40 (UNII: WZB9127XOA)  
Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Triacetin (UNII: XHX3C3X673)  
Triethyl Citrate (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code CYSTEX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69693-513-241 in 1 CARTON06/01/2022
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69693-513-481 in 1 CARTON06/01/2022
248 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2022
Labeler - Clarion Brands, LLC (079742703)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(69693-513)

Revised: 12/2023
Document Id: 74264a2c-679d-4574-b9e7-3086777baaf0
Set id: 4fe33a01-90de-451e-8b54-d84304c842d9
Version: 2
Effective Time: 20231222
 
Clarion Brands, LLC