{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Formula 3 Cough Syrup Cough Syrup PELARGONIUM SIDOIDES ROOT PELARGONIUM SIDOIDES ROOT PRUNUS SEROTINA BARK PRUNUS SEROTINA BARK SAMBUCUS NIGRA FLOWER SAMBUCUS NIGRA FLOWER HONEY AMERICAN ELDERBERRY CITRIC ACID MONOHYDRATE WATER ALCOHOL POTASSIUM SORBATE STEVIA LEAF XANTHAN GUM RASPBERRY NATURAL FLAVOR MIXED BERRY NATURAL FLAVOR"
      ],
      "active_ingredient": [
        "Formula 3 Cough Syrup Unckaloabo (Pelargonium sidoides) 1X Wild Cherry Bark (Prunus serotina) 1X European Elderberry (Sambucus nigra) 1X"
      ],
      "inactive_ingredient": [
        "Formula 3 Cough Syrup Buckwheat Honey, Elderberry Extract, Citric Acid, USP Purified Water, Natural Mixed Berry and Raspberry Flavor, Potassium Sorbate, Stevia, Xanthan Gum"
      ],
      "warnings": [
        "Formula 3 Cough Syrup Do not give product for persistent or chronic cough such as occurs with asthma or if cough is accompanied excessive phlegm (mucus) unless directed by doctor. Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as a persistent cough may be a sign of a serious condition. 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."
      ],
      "keep_out_of_reach_of_children": [
        "Formula 3 Cough Syrup Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "indications_and_usage": [
        "Formula 3 Cough Syrup Temprarily relieves symptoms of cough including dryness and minor throat and bronchial irritation associated with the common cold."
      ],
      "purpose": [
        "Formula 3 Cough Syrup Umckaloabo - Cough Suppressant Wild Cherry Bark - Cough Suppressant European Elderberry - Cough Suppressant"
      ],
      "dosage_and_administration": [
        "Formula 3 Cough Formula - Children 2 to 4 years of age: 1/2 teaspoon every 3 hours, or as needed. - Children 5 to 11 years of age: 1 teaspoon every 3 hours, or as needed. Children under 2 years of age: Consult your healthcare practitioner"
      ],
      "package_label_principal_display_panel": [
        "Formula 3 Cough Formula Label"
      ],
      "set_id": "199bbe91-ebfe-45fa-acba-62b35c7e6fba",
      "id": "462f5bc0-eea2-2be8-e063-6294a90a958d",
      "effective_time": "20251217",
      "version": "9",
      "openfda": {
        "brand_name": [
          "Formula 3 Cough Syrup"
        ],
        "generic_name": [
          "COUGH SYRUP"
        ],
        "manufacturer_name": [
          "Vitality Works, Inc."
        ],
        "product_ndc": [
          "64616-072"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PELARGONIUM SIDOIDES ROOT",
          "PRUNUS SEROTINA BARK",
          "SAMBUCUS NIGRA FLOWER"
        ],
        "spl_id": [
          "462f5bc0-eea2-2be8-e063-6294a90a958d"
        ],
        "spl_set_id": [
          "199bbe91-ebfe-45fa-acba-62b35c7e6fba"
        ],
        "package_ndc": [
          "64616-072-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0608274109506"
        ],
        "unii": [
          "H6J53HEX8E",
          "5D48E975HA",
          "07V4DX094T"
        ]
      }
    }
  ]
}