Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ac0f9a8c-164a-4908-8b1d-bb714a82550d
Route
ORAL
Published
Effective Date 2024-09-17
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 Powdered Cellulose Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Silicon Dioxide Stearic Acid Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: CYSTEX Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Methenamine 162 mg Antibacterial Sodium Salicylate 162.5 mg (NSAID*) *nonsteroidal anti-inflammatory drug.....Analgesic (pain reliever)

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Methenamine 162 mg Antibacterial Sodium Salicylate 162.5 mg (NSAID*) *nonsteroidal anti-inflammatory drug.....Analgesic (pain reliever)

Uses

temporarily relieves pain, burning, frequency and urgency of urination

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.

Section 53414-9

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. 

Purposes

Antibacterial

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
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.

Do Not Use
  • if you are allergic to salicylates (including aspirin)
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
Active Ingredients
Methenamine 162 mg Antibacterial
Sodium Salicylate 162.5 mg (NSAID*) *nonsteroidal anti-inflammatory drug.....Analgesic (pain reliever)

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

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
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

Structured Label Content

Uses

temporarily relieves pain, burning, frequency and urgency of urination

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.

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 (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. 

Purposes

Antibacterial

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
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.

Do Not Use (Do not use)
  • if you are allergic to salicylates (including aspirin)
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
Active Ingredients
Methenamine 162 mg Antibacterial
Sodium Salicylate 162.5 mg (NSAID*) *nonsteroidal anti-inflammatory drug.....Analgesic (pain reliever)

Inactive Ingredients (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 (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

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)
  • 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 Are (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 (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

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