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

Purpose

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

Description

Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID)* *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
Indications and Usage

Use temporarily relieves

  • pain & burning
  • frequency and urgency of urination
Purpose

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

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

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

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

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

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
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

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
Indications and Usage (34067-9)

Use temporarily relieves

  • pain & burning
  • frequency and urgency of urination
Purpose

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

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

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)

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

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
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

Advanced Ingredient Data


Raw Label Data

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