Cystex
Methenamine, Sodium Salicylate
Clarion Brands, Llc
Human Otc Drug
NDC 69693-513Cystex also known as Methenamine, Sodium Salicylate is a human otc drug labeled by 'Clarion Brands, Llc'. National Drug Code (NDC) number for Cystex is 69693-513. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cystex drug includes Methenamine - 162 mg/1 Sodium Salicylate - 162.5 mg/1 . The currest status of Cystex drug is Active.
Drug Information:
| Drug NDC: | 69693-513 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cystex |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Methenamine, Sodium Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Clarion Brands, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | METHENAMINE - 162 mg/1
SODIUM SALICYLATE - 162.5 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Clarion Brands, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1489932
1489934
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | J50OIX95QV
WIQ1H85SYP
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69693-513-24 | 1 BLISTER PACK in 1 CARTON (69693-513-24) / 24 TABLET in 1 BLISTER PACK | 01 Jun, 2022 | N/A | No |
| 69693-513-48 | 1 BLISTER PACK in 1 CARTON (69693-513-48) / 48 TABLET in 1 BLISTER PACK | 01 Jun, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose methenamine............antibacterial sodium salicylate.....analgesic (pain reliever)
Product Elements:
Cystex methenamine, sodium salicylate methenamine methenamine sodium salicylate salicylic acid 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 cystex carton blister pack
Indications and Usage:
Use temporarily relieves pain & burning frequency and urgency of urination
Warnings:
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:
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
When Using:
When using this product do not take more than the recommended dosage
Dosage and Administration:
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.
Stop Use:
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
Package Label 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 eas y⢠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 eas y⢠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: â are age 60 or older â have stomach ulcers or bleeding problems â take a blood thinner (anticoagulant) or steroid drug â take other drugs containing an nsaid (aspirin, ibuprofen, naproxen, or others) â have 3 or more alcoholic drinks every day while using this product â 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
Further Questions:
Questions or comments? 1-844-297-8394