CYSTEX  PLUS- 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

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 three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or problems during delivery. 

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

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

CYSTEX® 
Urinary Pain Relief (NSAID)


Max Strength+

Fast relief of pain & burning plus
helps control infection

40 Tablets

The Original Brand of Antibacterial Protection
Plus Pain Relief

ANTIBACTERIAL PROTECTION + PAIN RELIEF

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

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

For more information on Cystex tablets or Urinary Tract
infection please visit www.cystex.com or call 844-297-8394.

Distributed by:  Clarion Brands, LLC
27070 Miles Road, Suite A Solon,
OH 44139  3004I ©2019

carton

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 

Blister Pack
CYSTEX   PLUS
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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)  
Powdered Cellulose (UNII: SMD1X3XO9M)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Fd&c Red No. 40 (UNII: WZB9127XOA)  
Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
Hydroxypropyl Cellulose (1600000 Wamw) (UNII: RFW2ET671P)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Triethyl Citrate (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code CYSTEX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69693-512-401 in 1 CARTON05/01/2016
140 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69693-512-201 in 1 CARTON05/01/2016
220 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/01/2015
Labeler - Clarion Brands, LLC (079742703)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004PACK(69693-512)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757MANUFACTURE(69693-512)

Revised: 12/2020
Document Id: d5fcb610-9a61-406a-8523-e2e959a37569
Set id: 62200228-be42-1cda-9493-02bb491537c8
Version: 4
Effective Time: 20201211
 
Clarion Brands, LLC