{
  "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": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Real Relief Natural Wellness Calming Syrup asafoetida, strychnos ignatii seed (ignatia amara), valeriana officinalis whole (valeriana officinalis), oat bran (avena sativa), silver nitrate (argentum nitricum), hyoscyamus niger, paeonia officinalis root (paeonia officinalis), datura stramonium, anamirta cocculus whole (cocculus indicus) WATER SORBITOL CARAMEL SODIUM BENZOATE POTASSIUM SORBATE CITRIC ACID MONOHYDRATE FERULA ASSA-FOETIDA RESIN ASAFETIDA STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED VALERIANA OFFICINALIS WHOLE VALERIANA OFFICINALIS WHOLE OAT BRAN OAT BRAN SILVER NITRATE SILVER CATION HYOSCYAMUS NIGER HYOSCYAMUS NIGER PAEONIA OFFICINALIS ROOT PAEONIA OFFICINALIS ROOT DATURA STRAMONIUM DATURA STRAMONIUM ANAMIRTA COCCULUS WHOLE ANAMIRTA COCCULUS WHOLE"
      ],
      "active_ingredient": [
        "Active Ingredients ASAFOETIDA (ASAFETIDA) 8 [hp-X] IGNATIA AMARA (IGNATUS BEAN) 8 [hp-X] VALERIANA OFFICINALIS (VALERIAN) 8 [hp-X] AVENA SATIVA (OAT) 8 [hp-X] ARGENTUM NITRICUM (SILVER NITRATE) 8 [hp-X] HYOSCYAMUS NIGER (HENBANE) 8 [hp-X] PAEONIA OFFICINALIS (PEONY) 8 [hp-X] STRAMONIUM (THORN APPLE) 8 [hp-X] ANCOCCULUS INDICUS (INDIAN BERRY) 8 [hp-X] The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States."
      ],
      "purpose": [
        "Purpose ASAFOETIDA Restlessness and Anxiety IGNATIA AMARA Nervousness VALERIANA OFFICINALIS Agitation AVENA SATIVA Sleeplessness ARGENTUM NITRICUM Nervousness ARGENTUM NITRICUM Nervousness HYOSCYAMUS NIGER Anguish and fear PAEONIA OFFICINALIS Apprehension, anxiety and irritability STRAMONIUM Nightmares and nervousness COCCULUS INDICUS Lack of concentration"
      ],
      "indications_and_usage": [
        "Uses This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares. *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence."
      ],
      "warnings": [
        "Warnings Stop use and ask a doctor if symptoms worsen: If you are pregnant or breast feeding , ask a health professional before. Keep out of reach of children . In case of accidental overdose, contact a medical professional or poison control center immediately."
      ],
      "keep_out_of_reach_of_children": [
        ""
      ],
      "dosage_and_administration": [
        "Directions • Do not exceed recommended dosage • Repeat every 6 hours and reduce with improvement or as directed by a health professional. Age………………………………………………………….................Dose Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (tsp) Children 6 to 11 years of age. ...............................................5 ml or 1 teaspoon (tsp) Children 2 to 5 years of age. .................................................2.5 ml or ½ teaspoon (tsp)"
      ],
      "storage_and_handling": [
        "Other information Store at room temperature.• Do not use if seal is broken or missing *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid."
      ],
      "package_label_principal_display_panel": [
        "Product label image description image description"
      ],
      "set_id": "fb8c8d6d-3c7a-459d-97a8-d9094f3d546c",
      "id": "ec97a8da-436c-e7e0-e053-2a95a90a7b7f",
      "effective_time": "20221103",
      "version": "3",
      "openfda": {
        "brand_name": [
          "Real Relief Natural Wellness Calming Syrup"
        ],
        "generic_name": [
          "ASAFOETIDA, STRYCHNOS IGNATII SEED (IGNATIA AMARA), VALERIANA OFFICINALIS WHOLE (VALERIANA OFFICINALIS), OAT BRAN (AVENA SATIVA), SILVER NITRATE (ARGENTUM NITRICUM), HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT (PAEONIA OFFICINALIS), DATURA STRAMONIUM, ANAMIRTA COCCULUS WHOLE (COCCULUS INDICUS)"
        ],
        "manufacturer_name": [
          "Homeolab International (Canada) inc"
        ],
        "product_ndc": [
          "71971-9042"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ANAMIRTA COCCULUS WHOLE",
          "DATURA STRAMONIUM",
          "FERULA ASSA-FOETIDA RESIN",
          "HYOSCYAMUS NIGER",
          "OAT BRAN",
          "PAEONIA OFFICINALIS ROOT",
          "SILVER NITRATE",
          "STRYCHNOS IGNATII SEED",
          "VALERIANA OFFICINALIS WHOLE"
        ],
        "spl_id": [
          "ec97a8da-436c-e7e0-e053-2a95a90a7b7f"
        ],
        "spl_set_id": [
          "fb8c8d6d-3c7a-459d-97a8-d9094f3d546c"
        ],
        "package_ndc": [
          "71971-9042-5"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8O4P2U3QO2",
          "G6W4F0V8Z3",
          "W9FZA51AS1",
          "4WRK2153H3",
          "KQX236OK4U",
          "8R564U2E1P",
          "95IT3W8JZE",
          "1NM3M2487K",
          "FP6O7F1X9R"
        ]
      }
    }
  ]
}