{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION ONION ONION APIS MELLIFERA APIS MELLIFERA ATROPA BELLADONNA ATROPA BELLADONNA EUPATORIUM PERFOLIATUM FLOWERING TOP EUPATORIUM PERFOLIATUM FLOWERING TOP GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT DICHROMATE ION DICHROMATE ION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT PULSATILLA VULGARIS PULSATILLA VULGARIS CROSCARMELLOSE SODIUM LACTOSE MAGNESIUM STEARATE BOIRON ;"
      ],
      "active_ingredient": [
        "Active ingredients** (in each tablet) Allium cepa 3C HPUS (0.28 mg) Apis mellifica 6C HPUS (0.28 mg) Belladonna 6C HPUS (0.28 mg) (contains less than 10 -14 mg atropine alkaloids) Eupatorium perfoliatum 3C HPUS (0.28 mg) Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 -14 gelsemine alkaloids) Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 -13 mg chromium) Nux vomica 3C HPUS (0.28 mg) (contains less than 10 -8 mg strychnine alkaloids) Phytolacca decandra 6C HPUS (0.28 mg) Pulsatilla 6C HPUS (0.28 mg) The letters \"HPUS\" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States."
      ],
      "purpose": [
        "Purpose* Allium cepa 3C HPUS ... Relieves sneezing and runny nose Apis mellifica 6C HPUS ... Relieves nasal congestion Belladonna 6C HPUS ... Relieves colds with a sudden onset Eupatorium perfoliatum 3C HPUS ... Relieves aches and pain associated with colds Gelsemium sempervirens 6C HPUS ... Relieves headaches associated with colds Kali bichromicum 6C HPUS ... Relieves nasal discharge Nux vomica 3C HPUS .... Relieves sneezing fits Phytolacca decandra 6C HPUS ... Relieves occasional minor sore throat associated with colds Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell"
      ],
      "indications_and_usage": [
        "Uses* temporarily relieves cold symptoms such as: sneezing runny nose nasal congestion occasional minor sore throat"
      ],
      "warnings": [
        "Do not use if you are allergic to Apis."
      ],
      "ask_doctor": [
        "Ask a doctor before use in children under 4 years of age if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sore throat worsens or persists for more than 2 days nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults new symptoms occur"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding , ask a health professional before use."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets every 6 hours. Decrease frequency with improvement. Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above."
      ],
      "spl_unclassified_section": [
        "do not use if glued carton end flaps are open or if the blister seal is broken store below 86° F (30° C) Contains 20 meltaway tablets unflavored Contains 60 meltaway tablets unflavored Contains 100 meltway tablets unflavored Contains 120 meltaway tablets unflavored No Known Drug Interactions Phenylephrine-free Non-Drowsy Cold Relief* Sneezing, Runny Nose, Minor Sore Throat* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details."
      ],
      "inactive_ingredient": [
        "croscarmellose sodium, lactose, magnesium stearate"
      ],
      "questions": [
        "Questions or comments ColdCalm.com BoironUSA.com Info@Boiron.com 1-800-BOIRON-1 (1-800-264-7661) Distributed by Boiron, Inc. Newtown Square, PA 19073 Made in France"
      ],
      "package_label_principal_display_panel": [
        "label LABEL LABEL LABEL LABEL label label label label label label label label label label label"
      ],
      "set_id": "af4a4765-8255-44fb-821c-4345a2a45e2a",
      "id": "31bbb16b-e155-90c4-e063-6394a90af542",
      "effective_time": "20250401",
      "version": "14",
      "openfda": {
        "brand_name": [
          "Coldcalm"
        ],
        "generic_name": [
          "ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION"
        ],
        "manufacturer_name": [
          "Laboratoires Boiron"
        ],
        "product_ndc": [
          "0220-9048"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "APIS MELLIFERA",
          "ATROPA BELLADONNA",
          "DICHROMATE ION",
          "EUPATORIUM PERFOLIATUM FLOWERING TOP",
          "GELSEMIUM SEMPERVIRENS ROOT",
          "ONION",
          "PHYTOLACCA AMERICANA ROOT",
          "PULSATILLA VULGARIS",
          "STRYCHNOS NUX-VOMICA SEED"
        ],
        "spl_id": [
          "31bbb16b-e155-90c4-e063-6394a90af542"
        ],
        "spl_set_id": [
          "af4a4765-8255-44fb-821c-4345a2a45e2a"
        ],
        "package_ndc": [
          "0220-9048-04",
          "0220-9048-29",
          "0220-9048-91",
          "0220-9048-92"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185021",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0002274",
          "N0000185371",
          "M0006342",
          "M0022575",
          "N0000185375",
          "M0016962",
          "M0516536"
        ],
        "pharm_class_epc": [
          "Standardized Insect Venom Allergenic Extract [EPC]",
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Bee Venoms [CS]",
          "Dietary Proteins [CS]",
          "Vegetable Proteins [CS]",
          "Plant Proteins [CS]",
          "Seed Storage Proteins [CS]"
        ],
        "unii": [
          "7S82P3R43Z",
          "WQZ3G9PF0H",
          "9LKY4BFN2V",
          "1W0775VX6E",
          "639KR60Q1Q",
          "492225Q21H",
          "11E6VI8VEG",
          "I76KB35JEV",
          "269XH13919"
        ]
      }
    }
  ]
}