Cystex Plus

Dosage form: tablet
Ingredients: Methenamine 162mg, Sodium Salicylate 162.5mg
Labeler: DSE Healthcare Solutions, LLC
NDC Code: 42364-4501

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 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:

  • painful urination
  • burning 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

  • 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

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

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

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

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

  • 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

 

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 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

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(800) 331-0221

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.

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

CYSTEX   PLUS
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42364-4501
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methenamine (Methenamine) Methenamine162 mg
Sodium Salicylate (Salicylic Acid) Sodium Salicylate162.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeCYSTEX
Contains    
Packaging
#Item CodePackage Description
1NDC:42364-4501-110 TABLET (TABLET) in 1 BOTTLE
2NDC:42364-4501-440 TABLET (TABLET) in 1 CARTON
3NDC:42364-4501-2100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2012
Labeler - DSE Healthcare Solutions, LLC (603016069)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757MANUFACTURE(42364-4501)

Revised: 05/2012
 
DSE Healthcare Solutions, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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