{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 100,
      "total": 2
    }
  },
  "results": [
    {
      "effective_time": "20090709",
      "inactive_ingredient": [
        "Inactive ingredients Antifoam Emulsion, Caramel, Eucalyptus Oil, Gum Crystal, Menthol, and Sorbitol."
      ],
      "purpose": [
        "Purpose Oral Anesthetic"
      ],
      "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."
      ],
      "warnings": [
        "Warnings When using this product Do not use more than directed. Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product Do not use more than directed."
      ],
      "questions": [
        "QUESTIONS? Call 1-800-344-7239 or visit our website at www.insightpharma.com"
      ],
      "spl_product_data_elements": [
        "Cepastat Extra Strength Phenol Phenol Phenol Caramel Eucalyptus Oil Menthol Sorbitol transparent"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions dissolve a lozenge slowly in mouth adults and children 12 years and older take up to 2 lozenges every 2 hours as needed children 6 to under 12 years take up to 1 lozenge every 2 hours; not more than 10 lozenges in 24 hours children under 6 years ask a doctor"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens"
      ],
      "storage_and_handling": [
        "Other Information Store at room temperature, below 86°F (30°C). Protect contents from humidity."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 18 Lozenges carton MENTHOL EUCALYPTUS FLAVOR CĒPASTAT ® ORAL ANESTHETIC WITH PHENOL FAST ACTING SORE THROAT RELIEF EXTRA STRENGTH* 18 LOZENGES SUGAR FREE Principle Display Panel - 18 Lozenges carton"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves minor sore throat pain sore mouth minor mouth irritation pain associated with canker sores"
      ],
      "set_id": "1613c687-411e-487d-b672-a3d849d53e5f",
      "id": "a33617f8-fc6a-4c06-8f96-fed5b5d6d570",
      "active_ingredient": [
        "Active ingredient (per lozenge) Phenol 29 mg"
      ],
      "dosage_and_administration_table": [
        "<table width=\"50%\"> <col width=\"55%\" align=\"left\" valign=\"middle\"/> <col width=\"45%\" align=\"left\" valign=\"middle\"/> <tbody> <tr styleCode=\"TopRule\"> <td styleCode=\"Rrule BotRule\">adults and children 12 years and older</td> <td styleCode=\"BotRule\">take up to 2 lozenges every 2 hours as needed</td> </tr> <tr styleCode=\"BotRule\"> <td styleCode=\"Rrule\">children 6 to under 12 years</td> <td>take up to 1 lozenge every 2 hours; not more than 10 lozenges in 24 hours</td> </tr> <tr styleCode=\"BotRule\"> <td styleCode=\"Rrule\">children under 6 years</td> <td>ask a doctor</td> </tr> </tbody> </table>"
      ]
    },
    {
      "effective_time": "20090709",
      "inactive_ingredient": [
        "Inactive ingredients Antifoam Emulsion, D&C Red No.33, FD&C Yellow No.6, Flavor, Gum Crystal, Menthol, Saccharin Sodium, and Sorbitol."
      ],
      "purpose": [
        "Purpose Oral Anesthetic"
      ],
      "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."
      ],
      "warnings": [
        "Warnings When using this product Do not use more than directed. Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product Do not use more than directed."
      ],
      "questions": [
        "QUESTIONS? Call 1-800-344-7239 or visit our website at www.insightpharma.com"
      ],
      "spl_product_data_elements": [
        "Cepastat Cherry Phenol PHENOL PHENOL D&C RED NO. 33 FD&C YELLOW NO. 6 MENTHOL SACCHARIN SODIUM SORBITOL Hot Pink"
      ],
      "openfda": {},
      "version": "3",
      "dosage_and_administration": [
        "Directions dissolve a lozenge slowly in mouth adults and children 12 years and older take up to 2 lozenges every 2 hours as needed children 6 to under 12 years take up to 1 lozenge every 2 hours; not more than 18 lozenges in 24 hours children under 6 years ask a doctor"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens"
      ],
      "storage_and_handling": [
        "Other Information Store at room temperature, below 86°F (30°C). Protect contents from humidity."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 18 Lozenges Carton CHERRY CĒPASTAT ® ORAL ANESTHETIC WITH PHENOL FAST ACTING SORE THROAT RELIEF 18 LOZENGES SUGAR FREE Principle Display Panel - 18 Lozenges Carton"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves minor sore throat pain sore mouth minor mouth irritation pain associated with canker sores"
      ],
      "set_id": "6f4402aa-3f6e-4469-b512-868dba734d2b",
      "id": "c626ce4a-1897-471e-bcff-cd3717ba6c53",
      "active_ingredient": [
        "Active ingredient (per lozenge) Phenol 14.5mg"
      ],
      "dosage_and_administration_table": [
        "<table> <col width=\"50%\"/> <col width=\"50%\"/> <tbody> <tr> <td styleCode=\"     Rrule     \"> adults and children 12 years and older</td> <td valign=\"top\"> take up to 2 lozenges every 2 hours as needed</td> </tr> <tr> <td styleCode=\"     Rrule     \"> children 6 to under 12 years</td> <td valign=\"top\"> take up to 1 lozenge every 2 hours; not more than 18 lozenges in 24 hours</td> </tr> <tr> <td styleCode=\"     Rrule     \"> children under 6 years</td> <td valign=\"top\"> ask a doctor</td> </tr> </tbody> </table>"
      ]
    }
  ]
}