Label: CYSTEX- methenamine, sodium salicylate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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
    OTC Monograph Drug505G(a)(3)06/01/2022
    Labeler - Clarion Brands, LLC (079742703)