{
  "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": "2026-07-18",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "CALCAREA SULFURICA 6X Calcium Sulfate CALCIUM SULFATE ANHYDROUS CALCIUM CATION MAGNESIUM STEARATE LACTOSE MONOHYDRATE CARBOXYMETHYLCELLULOSE SODIUM XYLITOL"
      ],
      "active_ingredient": [
        "Active ingredients Calcarea sulphurica (Calcium sulfate) 6X"
      ],
      "purpose": [
        "For the temporary relief of symptoms associated with skin irritation tender gums"
      ],
      "warnings": [
        "Warnings Do not use if you ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breastfeeding, 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."
      ],
      "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"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding, ask a health professional before use."
      ],
      "other_safety_information": [
        "Other information Do not use if seal is missing or broken. Store in a cool, dry place."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Lactose monohydrate (milk), magnesium stearate, sodium carboxymethylcellulose, xylitol"
      ],
      "dosage_and_administration": [
        "Directions Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and adolescents (12 years and older) Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner."
      ],
      "indications_and_usage": [
        "Uses For the temporary relief of symptoms associated with skin irritation tender gums Directions Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and adolescents (12 years and older) Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner."
      ],
      "package_label_principal_display_panel": [
        "UNDA tissue salt CALCAREA SULFURICA 6X Homeopathic Remedy Schuessler Salt For the temporary relief of symptoms associated with skin irritation and tender gum. 100 Tablets CALCAREA SULFURICA 6X"
      ],
      "set_id": "58250ce3-b476-493e-e053-2a91aa0a4fef",
      "id": "e33c2bf0-12c5-7d66-e053-2a95a90aea41",
      "effective_time": "20220707",
      "version": "3",
      "openfda": {
        "brand_name": [
          "CALCAREA SULFURICA 6X"
        ],
        "generic_name": [
          "CALCIUM SULFATE"
        ],
        "manufacturer_name": [
          "Seroyal USA"
        ],
        "product_ndc": [
          "62106-1052"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "SUBLINGUAL"
        ],
        "substance_name": [
          "CALCIUM SULFATE ANHYDROUS"
        ],
        "spl_id": [
          "e33c2bf0-12c5-7d66-e053-2a95a90aea41"
        ],
        "spl_set_id": [
          "58250ce3-b476-493e-e053-2a91aa0a4fef"
        ],
        "package_ndc": [
          "62106-1052-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "E934B3V59H"
        ]
      }
    }
  ]
}