drug facts

drug facts
SPL v13
SPL
SPL Set ID 62200228-be42-1cda-9493-02bb491537c8
Route
oral
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
methenamine (162 mg) salicylic acid (162.5 mg)
Inactive Ingredients
benzoic acid croscarmellose sodium fd&c red no. 40 fd&c yellow no. 6 hypromellose, unspecified magnesium stearate methacrylic acid and ethyl acrylate copolymer microcrystalline cellulose silicon dioxide stearic acid sodium bicarbonate sodium lauryl sulfate talc titanium dioxide triacetin triethyl citrate

Identifiers & Packaging

Pill Appearance
Imprint: CYSTEX Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
unapproved drug other active Since 2015-11-01

Description

Active ingredients (in each tablet) Purposes Methenamine 162 mg Antibacterial Sodium Salicylate 162.5 mg (NSAID)* Analgesic (Pain Reliever) * nonsteroidal anti-inflammatory drug  


Medication Information

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
Active Ingredient
Active ingredients (in each tablet) Purposes
Methenamine 162 mg Antibacterial
Sodium Salicylate 162.5 mg (NSAID)* Analgesic (Pain Reliever)
* nonsteroidal anti-inflammatory drug  
Indications and Usage

Uses temporarily relieves

  • pain & burning
  • frequency and urgency of urination
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

Description

Active ingredients (in each tablet) Purposes Methenamine 162 mg Antibacterial Sodium Salicylate 162.5 mg (NSAID)* Analgesic (Pain Reliever) * nonsteroidal anti-inflammatory drug  

Principal Display Panel

VALUE SIZE! 2x More Tablets



MAX STRENGTH



Cystex ® 

Methenamine 162 mg ANTIBACTERIAL ∣ Sodium Salicylate 162.5 mg (NSAID) PAIN RELIEVER



UTI PAIN RELIEF



UTI BACTERIA CONTROL



Fast relief of pain & burning

plus helps control UTI bacteria



Maximum Strength UTI Pain Relief



Formulated without Urine Discoloring Ingredients



#1 OTC Ingredient for UTI Bacteria Control* 



Does not contain urine coloring agents as found in 

other leading UTI products

Compared to 2023 leading UTI Relief Brands          



48 Tablets



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



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



1000221



REV 7/23 CSTX048BRI




MAX STRENGTH



Cystex ®

Urinary Health Made Easy™



For more information on Cystex

UTI Pain Relief, other products,

or Urinary Tract Infections (UTIs)

please visit www.cyxtex.com

or call 844-297-8394



MAX STRENGTH



Cystex ®

Urinary Health Made Easy™



Distributed by: Cystex, LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402 @2023



*Source: IRI Sales Data, 2023



P16919

48ct.



Knockout for Expiration

Date and Lot Number

                     Principal Display for Blister Pack

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

Section 50565-1

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.

Section 53414-9

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. 

Do Not Use
  • if you are allergic to salicylates (including aspirin)
Questions Or Comments?

1-844-297-8394

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
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

Structured Label Content

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
Active Ingredient (55106-9)
Active ingredients (in each tablet) Purposes
Methenamine 162 mg Antibacterial
Sodium Salicylate 162.5 mg (NSAID)* Analgesic (Pain Reliever)
* nonsteroidal anti-inflammatory drug  
Indications and Usage (34067-9)

Uses temporarily relieves

  • pain & burning
  • frequency and urgency of urination
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 (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 (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

VALUE SIZE! 2x More Tablets



MAX STRENGTH



Cystex ® 

Methenamine 162 mg ANTIBACTERIAL ∣ Sodium Salicylate 162.5 mg (NSAID) PAIN RELIEVER



UTI PAIN RELIEF



UTI BACTERIA CONTROL



Fast relief of pain & burning

plus helps control UTI bacteria



Maximum Strength UTI Pain Relief



Formulated without Urine Discoloring Ingredients



#1 OTC Ingredient for UTI Bacteria Control* 



Does not contain urine coloring agents as found in 

other leading UTI products

Compared to 2023 leading UTI Relief Brands          



48 Tablets



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



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



1000221



REV 7/23 CSTX048BRI




MAX STRENGTH



Cystex ®

Urinary Health Made Easy™



For more information on Cystex

UTI Pain Relief, other products,

or Urinary Tract Infections (UTIs)

please visit www.cyxtex.com

or call 844-297-8394



MAX STRENGTH



Cystex ®

Urinary Health Made Easy™



Distributed by: Cystex, LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402 @2023



*Source: IRI Sales Data, 2023



P16919

48ct.



Knockout for Expiration

Date and Lot Number

                     Principal Display for Blister Pack

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

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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. 

Do Not Use (Do not use)
  • if you are allergic to salicylates (including aspirin)
Questions Or Comments? (Questions or comments?)

1-844-297-8394

When Using This Product (When using this product)
  • do not take more than the recommended dosage
Stop Use and Ask A Doctor If (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
Ask A Doctor Before Use If You Have (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 (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)