Label: CYSTEX PLUS- methenamine, sodium salicylate tablet
- NDC Code(s): 69693-512-20, 69693-512-40
- Packager: Clarion Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 11, 2020
If you are a consumer or patient please visit this version.
- Active Ingredients (in each tablet):
- INDICATIONS & USAGE
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 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
- Do not use
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
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 three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or problems during delivery.
- Keep out of reach of children
- Other Information
- Inactive ingredients
PRINCIPAL DISPLAY PANEL
Urinary Pain Relief (NSAID)
Fast relief of pain & burning plus
helps control infection
The Original Brand of Antibacterial Protection
Plus Pain Relief
ANTIBACTERIAL PROTECTION + PAIN RELIEF
Guaranteed Satisfaction, If you are not completely satisfied, send us a copy of your cash register receipt, UPC code # along with your full name and address and we will replace or refund your purchase. Limit one refund per household.
USE ONLY IF BLISTER UNIT IS UNBROKEN
Cystex is not intended to replace a doctor's care.
For more information on Cystex tablets or Urinary Tract
infection please visit www.cystex.com or call 844-297-8394.
Distributed by: Clarion Brands, LLC
27070 Miles Road, Suite A Solon,
OH 44139 3004I ©2019
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
CLARION BRANDS, LLC. 1-844-297-8394 5003
INGREDIENTS AND APPEARANCE
methenamine, sodium salicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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) Powdered Cellulose (UNII: SMD1X3XO9M) Croscarmellose Sodium (UNII: M28OL1HH48) Fd&c Red No. 40 (UNII: WZB9127XOA) Fd&c Yellow No. 6 (UNII: H77VEI93A8) Hydroxypropyl Cellulose (1600000 Wamw) (UNII: RFW2ET671P) Hypromelloses (UNII: 3NXW29V3WO) Magnesium Stearate (UNII: 70097M6I30) Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J) Silicon Dioxide (UNII: ETJ7Z6XBU4) Stearic Acid (UNII: 4ELV7Z65AP) Titanium Dioxide (UNII: 15FIX9V2JP) 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:69693-512-40 1 in 1 CARTON 05/01/2016 1 40 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69693-512-20 1 in 1 CARTON 05/01/2016 2 20 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 11/01/2015 Labeler - Clarion Brands, LLC (079742703) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 PACK(69693-512) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 MANUFACTURE(69693-512)