{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Headache Drops 2027 Headache Drops ONION ONION GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT AMARYLLIS BELLADONNA WHOLE AMARYLLIS BELLADONNA WHOLE STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED SPIGELIA ANTHELMIA WHOLE SPIGELIA ANTHELMIA WHOLE COFFEA ARABICA SEED, ROASTED COFFEA ARABICA SEED, ROASTED LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE LACHESIS MUTA VENOM LACHESIS MUTA VENOM PULSATILLA MONTANA WHOLE PULSATILLA MONTANA WHOLE NITROGLYCERIN NITROGLYCERIN SODIUM CHLORIDE CHLORIDE ION ALCOHOL WATER"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Allium cepa 3X Gelsemium sempervirens 3X Belladonna 4X Nux vomica 4X Spigelia anthelmia 4X Coffea tosta 6X Lycopodium clavatum 6X Lachesis mutus 8X Pulsatilla 8X Glonoinum 12X Natrum muriaticum 12X"
      ],
      "questions": [
        "QUESTIONS Professional Formulas PO Box 2034 Lake Oswego, OR 97035"
      ],
      "indications_and_usage": [
        "INDICATIONS For the temporary relief of occasional headaches.*"
      ],
      "purpose": [
        "*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
      ],
      "warnings": [
        "WARNINGS Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding, ask a healthcare professional before use."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age."
      ],
      "other_safety_information": [
        "OTHER INFORMATION Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS 20% ethanol, purified water."
      ],
      "package_label_principal_display_panel": [
        "LABEL Est 1985 Professional Formulas Complementary Health Headache Drops Homeopathic Remedy 2 FL. OZ. (59 mL) Label image"
      ],
      "set_id": "a7e345fb-c4aa-4b10-8074-9d8c37304142",
      "id": "8dd979ec-346c-4041-a8b1-bd419e70cbeb",
      "effective_time": "20260108",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Headache Drops 2027"
        ],
        "generic_name": [
          "HEADACHE DROPS"
        ],
        "manufacturer_name": [
          "Professional Complementary Health Formulas"
        ],
        "product_ndc": [
          "63083-2027"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ONION",
          "GELSEMIUM SEMPERVIRENS ROOT",
          "AMARYLLIS BELLADONNA WHOLE",
          "STRYCHNOS NUX-VOMICA SEED",
          "SPIGELIA ANTHELMIA WHOLE",
          "COFFEA ARABICA SEED, ROASTED",
          "LYCOPODIUM CLAVATUM SPORE",
          "LACHESIS MUTA VENOM",
          "PULSATILLA MONTANA WHOLE",
          "NITROGLYCERIN",
          "SODIUM CHLORIDE"
        ],
        "spl_id": [
          "8dd979ec-346c-4041-a8b1-bd419e70cbeb"
        ],
        "spl_set_id": [
          "a7e345fb-c4aa-4b10-8074-9d8c37304142"
        ],
        "package_ndc": [
          "63083-2027-2"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0022575",
          "N0000185375",
          "N0000185001",
          "M0016962",
          "M0516536",
          "N0000175415",
          "M0014874",
          "N0000009909"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]",
          "Nitrate Vasodilator [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]",
          "Vasodilation [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Vegetable Proteins [CS]",
          "Plant Proteins [CS]",
          "Seed Storage Proteins [CS]",
          "Nitrates [CS]"
        ],
        "unii": [
          "492225Q21H",
          "639KR60Q1Q",
          "11B89M58UN",
          "269XH13919",
          "WYT05213GE",
          "9H58JRT35E",
          "C88X29Y479",
          "VSW71SS07I",
          "24K790T39B",
          "G59M7S0WS3",
          "451W47IQ8X"
        ]
      }
    }
  ]
}