Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 4fe33a01-90de-451e-8b54-d84304c842d9
Route
ORAL
Published
Effective Date 2022-04-22
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 - Ethyl Acrylate Copolymer (1:1) Type A 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 2022-06-01

Description

Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID)* *nonsteroidal anti-inflammatory drug  

Purpose

Methenamine............Antibacterial Sodium Salicylate.....Analgesic (pain reliever)


Medication Information

Indications and Usage

Use temporarily relieves

  • pain & burning
  • frequency and urgency of urination
Purpose

Methenamine............Antibacterial

Sodium Salicylate.....Analgesic (pain reliever)

Description

Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID)* *nonsteroidal anti-inflammatory drug  

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. 

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
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.

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

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
Active Ingredients (in Each Tablet)

Methenamine 162 mg

Sodium Salicylate 162.5 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

 

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

Indications and Usage (34067-9)

Use 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 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. 

Purpose

Methenamine............Antibacterial

Sodium Salicylate.....Analgesic (pain reliever)

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
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

Questions Or Comments? (Questions or comments?)

1-844-297-8394

Principal Display Panel (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.

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

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
Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Methenamine 162 mg

Sodium Salicylate 162.5 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

 

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

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Raw Label Data

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