Label: CYSTEX PLUS- methenamine and sodium salicylate tablet

  • NDC Code(s): 42364-4501-1, 42364-4501-2, 42364-4501-4
  • Packager: DSE Healthcare Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/12

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

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  • Purpose

    Methenamine............Antibacterial
    Sodium Salicylate.....Analgesic (pain reliever)

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  • Use

    temporarily relieves:

    • painful urination
    • burning urination

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  • 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

    • 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

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  • Do not use:

    • if you are on a sodium restricted diet

    • if you are allergic to salicylates

    • if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems

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  • Ask a doctor before use if you have

    • frequent, burning urination for the first time

    • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain

    • ulcers

    • taken a diuretic

    • bleeding problems

    • reached age 60 or older

    • high blood pressure

    • liver cirrhosis

    • heart or kidney disease

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  • 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) or steroid drug

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  • When using this product

    • do not take more than the recommended dosage

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  • Stop use and ask a doctor if

    • product has been used for 3 days

    • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

    • stomach pain or upset gets worse or lasts

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  •  

    If pregnant or breast feeding, ask a health professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • 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

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  • Other information

    • store at 59-86°F (15-30°C) in a dry place

    • protect from light

    • each tablet contains: 23.7 mg sodium
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  • Questions?

    call 1(800) 331-0221

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  • Inactive ingredients

    Benzoic Acid, Cellulose,Croscarmellose Sodium, Edible black 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.

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  • Package Label

    CYSTEX®
    PLUS

    URINARY PAIN RELIEF TABLETS

    FAST RESULTS!

    100 Tablets        See New Warnings Information

    Does Not Discolor Urine

    Relieves pain & burning
    Plus helps control infection*

    The ONLY brand that provides
    pain relief (NSAID)
    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

    Do not use if tamper resistant seal on
    bottle neck is broken or missing at time
    of purchase

    If you have any questions or difficulties finding this product, please go to our website: www.cystex.com
    Distributed by: DSE Healthcare Solutions, LLC, Edison, NJ 08818 Rev. 4/12 4007 www.dsehealth.com

    Carton Label
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  • INGREDIENTS AND APPEARANCE
    CYSTEX   PLUS
    methenamine, sodium salicylate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42364-4501
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Methenamine (Methenamine) Methenamine 162 mg
    Sodium Salicylate (Salicylic Acid) Sodium Salicylate 162.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    Benzoic Acid  
    Powdered Cellulose  
    Croscarmellose Sodium  
    Fd&c Red No. 40  
    Fd&c Yellow No. 6  
    Hydroxypropyl Cellulose  
    Hypromelloses  
    Magnesium Stearate  
    Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A  
    Silicon Dioxide  
    Stearic Acid  
    Titanium Dioxide  
    Triethyl Citrate  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code CYSTEX
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42364-4501-1 10 in 1 BOTTLE
    2 NDC:42364-4501-4 40 in 1 CARTON
    3 NDC:42364-4501-2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/01/2012
    Labeler - DSE Healthcare Solutions, LLC (603016069)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 MANUFACTURE(42364-4501)
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