Label: CYSTEX- methenamine, sodium salicylate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 December 22, 2023

If you are a consumer or patient 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 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

    • if you are allergic to salicylates (including aspirin)
  • Ask a doctor before use if you have

    • 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

    • 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

    • 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
    • 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.  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 REACH OF CHILDREN

    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:

    • 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

    • 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

    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
  • INGREDIENTS AND APPEARANCE
    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)