FDA Label for Cystex

Active Ingredients

Purposes

Antibacterial

Uses

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 Are

• 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

• 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 (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.

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, 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

Principal Display Panel

DUAL ACTION

Cystex^®
Urinary Health

Methenamine 162 mg | Sodium Salicylate 162.5 mg (NSAID)

PAIN RELIEF (NSAID)

+ UTI BACTERIA CONTROL

2-in-1 Formula to Help Slow UTI Bacteria
Growth and Provice General Pain Relief

Helps Control
UTI infection

Formulated for no
Urine Discoloration

#1 Ingredient for UTI BACTERIAL
Control* 

Cystex is not intended to replace a doctor's care.

24 Tablets

TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.

Distributed by: Cystex, LLC 811 Broad Street
Suite 600, Chattanooga, TN 37402 ©2024
Call 844-297-8394 or visit Cystex.com

*Source: IRI Sales Data, 2023.

Does not contain urine coloring agents as
found in other leading UTI products

1000288
Made In India
RA/Drug/RAJ.-1750

48 tablets

1000273