{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-29",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "UTI INFECTION CONTROL Methenamine, Sodium Salicylate BENZOIC ACID CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STEARIC ACID SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE METHENAMINE METHENAMINE SODIUM SALICYLATE SALICYLIC ACID PH061"
      ],
      "active_ingredient": [
        "Active Ingredient (in each tablet) Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID)* *nonsteroidal anti-inflammatory drug"
      ],
      "purpose": [
        "Purpose Antibacterial Analgesic (pain reliever)"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves: pain and 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. 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 non-steroidal 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 prescription or nonprescription NSAIDs (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": [
        "Do Not Use: if you are allergic to salicylates (including aspirin)"
      ],
      "ask_doctor": [
        "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 reached age 60 or older"
      ],
      "ask_doctor_or_pharmacist": [
        "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": [
        "When using this product: do not take more than the recommended dosage"
      ],
      "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 stool have stomach pain that gets worse or lasts"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding 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 reach of children In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222."
      ],
      "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. Do not use for more than a 3 day period unless directed by a doctor. Children under 12 years: ask a doctor."
      ],
      "other_safety_information": [
        "Other information each tablet contains 24.4 mg of sodium store at 59-86°F (15-30°C) in a dry place protect from light Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged."
      ],
      "inactive_ingredient": [
        "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 citrate"
      ],
      "spl_unclassified_section": [
        "MANUFACTURED FOR Cadence OTC, Oakland, CA 94612"
      ],
      "questions": [
        "Questions or comments: Call 1-877-862-7455 or visit us at cadenceotc.com"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cadence OTC UTI INFECTION CONTROL Antibacterial to help control a UTI METHENAMINE AND SODIUM SALICYLATE (NSAID) 2 day supply 12 tablets NOT INTENDED TO REPLACE MEDICAL CARE. CSDUALCAD Rev 1/26 Carton"
      ],
      "set_id": "4d249fbc-98cf-44e4-b347-1c056dcf3cf3",
      "id": "4ece7cbb-cba6-f159-e063-6294a90a99fc",
      "effective_time": "20260406",
      "version": "2",
      "openfda": {
        "brand_name": [
          "UTI INFECTION CONTROL"
        ],
        "generic_name": [
          "METHENAMINE, SODIUM SALICYLATE"
        ],
        "manufacturer_name": [
          "CADENCE HEALTH, INC."
        ],
        "product_ndc": [
          "73436-1221"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHENAMINE",
          "SODIUM SALICYLATE"
        ],
        "rxcui": [
          "1489932"
        ],
        "spl_id": [
          "4ece7cbb-cba6-f159-e063-6294a90a99fc"
        ],
        "spl_set_id": [
          "4d249fbc-98cf-44e4-b347-1c056dcf3cf3"
        ],
        "package_ndc": [
          "73436-1221-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "J50OIX95QV",
          "WIQ1H85SYP"
        ]
      }
    }
  ]
}