CYSTEX- methenamine, sodium salicylate tablet

Cystex by

Drug Labeling and Warnings

Cystex by is a Otc medication manufactured, distributed, or labeled by Clarion Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

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

Purpose

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

INDICATIONS & USAGE

Use 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 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

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

PREGNANCY OR BREAST FEEDING

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. 

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 1-800-222-1222.

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

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

INGREDIENTS AND APPEARANCE

CYSTEX 
methenamine, sodium salicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-513(NDC:69693-512)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methenamine (UNII: J50OIX95QV) (Methenamine - UNII:J50OIX95QV)	Methenamine	162 mg
Sodium Salicylate (UNII: WIQ1H85SYP) (Salicylic Acid - UNII:O414PZ4LPZ)	Sodium Salicylate	162.5 mg

Inactive Ingredients
Ingredient Name	Strength
Benzoic Acid (UNII: 8SKN0B0MIM)
Croscarmellose Sodium (UNII: M28OL1HH48)
Fd&c Red No. 40 (UNII: WZB9127XOA)
Fd&c Yellow No. 6 (UNII: H77VEI93A8)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Stearic Acid (UNII: 4ELV7Z65AP)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)
Triacetin (UNII: XHX3C3X673)
Triethyl Citrate (UNII: 8Z96QXD6UM)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CYSTEX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69693-513-24	1 in 1 CARTON	06/01/2022
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69693-513-48	1 in 1 CARTON	06/01/2022
2		48 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2022

Labeler - Clarion Brands, LLC (079742703)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(69693-513)