FDA Label for Cystex

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
  
  

Otc - 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. 

Otc - 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 - 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