CYSTEX  PLUS- methenamine, sodium salicylate tablet 
DSE Healthcare Solutions, LLC

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.

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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.

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
CYSTEX   PLUS
methenamine, sodium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42364-4501
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 (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:42364-4501-110 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201211/30/2018
2NDC:42364-4501-440 in 1 CARTON; Type 0: Not a Combination Product04/01/201211/30/2018
3NDC:42364-4501-2100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201211/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/201211/30/2018
Labeler - DSE Healthcare Solutions, LLC (603016069)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757MANUFACTURE(42364-4501)

Revised: 11/2018
 
DSE Healthcare Solutions, LLC