Label: CYSTEX- methenamine, sodium salicylate tablet
- NDC Code(s): 69693-513-24, 69693-513-48
- Packager: Clarion Brands, LLC
- This is a repackaged label.
- Source NDC Code(s): 69693-512
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
- INDICATIONS & USAGE
-
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
- Ask a doctor before use if you have
- 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 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
- Directions
- Other information
-
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?
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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 tabletProduct 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 OTC Monograph Drug 505G(a)(3) 06/01/2022 Labeler - Clarion Brands, LLC (079742703)