{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "TopCare Antibacterial Plus Urinary Pain Relief METHENAMINE, SODIUM SALICYLATE METHENAMINE METHENAMINE SODIUM SALICYLATE SALICYLIC ACID BENZOIC ACID CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE STEARIC ACID SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE PH061"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "HELPS CONTROL THE INFECTION* PLUS GENERAL PAIN RELIEVER Antibacterial Urinary Pain Relief Methenamine and Sodium Salicylate (NSAID)"
      ],
      "active_ingredient": [
        "Active Ingredients (in each tablet): Methenamine 162 mg Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)"
      ],
      "purpose": [
        "Purpose Antibacterial Analgesic (pain reliever)"
      ],
      "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."
      ],
      "indications_and_usage": [
        "Uses 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. If changes in behaviour 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 an NSAID, which may cause stomach bleeding. The chance is higher if you: • 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 • have stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • take more or for a longer time than directed Do not use: • if you are on a sodium restricted diet • if you are allergic to salicylates (including aspirin) unless directed by a doctor • if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a 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 • reached age 60 or older Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug When using this product • do not take more than the recommended dosage Stop and ask a doctor if • product has been used for 3 days • you experience any of the following signs of stomach bleeding: • feel faint, vomit blood • have bloody or black stools • have stomach pain that does not get better • ringing in the ears or a loss of hearing occurs If pregnant or breast feeding, ask a health professional before use."
      ],
      "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"
      ],
      "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"
      ],
      "storage_and_handling": [
        "Other Information: • each tablet contains 25 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."
      ],
      "package_label_principal_display_panel": [
        "Packaging carton"
      ],
      "set_id": "02af5576-d75c-4553-9431-9c482997c8bb",
      "id": "498de24d-a25d-44b9-a75d-596d77919f0c",
      "effective_time": "20241218",
      "version": "3",
      "openfda": {
        "brand_name": [
          "TopCare Antibacterial Plus Urinary Pain Relief"
        ],
        "generic_name": [
          "METHENAMINE, SODIUM SALICYLATE"
        ],
        "manufacturer_name": [
          "Topco Associates LLC"
        ],
        "product_ndc": [
          "36800-314"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHENAMINE",
          "SODIUM SALICYLATE"
        ],
        "rxcui": [
          "1489932"
        ],
        "spl_id": [
          "498de24d-a25d-44b9-a75d-596d77919f0c"
        ],
        "spl_set_id": [
          "02af5576-d75c-4553-9431-9c482997c8bb"
        ],
        "package_ndc": [
          "36800-314-24"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0036800444744"
        ],
        "unii": [
          "J50OIX95QV",
          "WIQ1H85SYP"
        ]
      }
    }
  ]
}