Label: CYSTEX PLUS- methenamine, sodium salicylate tablet

  • NDC Code(s): 69693-512-20, 69693-512-40
  • Packager: Clarion Brands, LLC
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated November 1, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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
  • 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

    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
  • INGREDIENTS AND APPEARANCE
    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)