{
  "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": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "COLD Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum ACACIA LACTOSE ACONITUM NAPELLUS ACONITUM NAPELLUS GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT ONION ONION ZINC GLUCONATE ZINC CATION"
      ],
      "purpose": [
        "Relieves Runny Nose, Congestion, Sore Throat, Cough, Sneezing, Headache and Fever"
      ],
      "spl_unclassified_section": [
        "Drug Facts Active ingredients Purpose Aconitum Napellus 6X HPUS sneezing, watery eyes, sore throat Allium Cepa 6X HPUS red/watery eyes, runny nose, nasal discharge Gelsemium Sempervirens 6X HPUS sneezing, headache, sore throat, cough Zincum Gluconicum 2X HPUS runny nose, sore throat \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.",
        "Drug Facts (continued) Other information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing.",
        "*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."
      ],
      "spl_unclassified_section_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Aconitum Napellus 6X HPUS</td><td>sneezing, watery eyes, sore throat</td></tr><tr><td>Allium Cepa 6X HPUS</td><td>red/watery eyes, runny nose, nasal discharge</td></tr><tr><td>Gelsemium Sempervirens 6X HPUS</td><td>sneezing, headache, sore throat, cough</td></tr><tr><td>Zincum Gluconicum 2X HPUS</td><td>runny nose, sore throat</td></tr></tbody></table>"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Aconitum Napellus 6X HPUS sneezing, watery eyes, sore throat Allium Cepa 6X HPUS red/watery eyes, runny nose, nasal discharge Gelsemium Sempervirens 6X HPUS sneezing, headache, sore throat, cough Zincum Gluconicum 2X HPUS runny nose, sore throat \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States."
      ],
      "active_ingredient_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Aconitum Napellus 6X HPUS</td><td>sneezing, watery eyes, sore throat</td></tr><tr><td>Allium Cepa 6X HPUS</td><td>red/watery eyes, runny nose, nasal discharge</td></tr><tr><td>Gelsemium Sempervirens 6X HPUS</td><td>sneezing, headache, sore throat, cough</td></tr><tr><td>Zincum Gluconicum 2X HPUS</td><td>runny nose, sore throat</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses ■ Reduces the duration and severity of common cold symptoms ■ Temporarily relieves symptoms of common cold, including: ■ sneezing ■ runny nose ■ congestion ■ cough ■ sore throat ■ headache ■ watery eyes ■ fever ■ chills"
      ],
      "warnings": [
        "Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever (over 101°F) or infection is present or develops. ■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache. Keep this and all medications out of the reach of children. Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional. A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by fever (over 101°F), headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659."
      ],
      "pregnancy_or_breast_feeding": [
        "As with any drug, ask a doctor before use if pregnant or breast-feeding."
      ],
      "do_not_use": [
        "Do not use more than directed.",
        "Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional."
      ],
      "ask_doctor": [
        "Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever (over 101°F) or infection is present or develops. ■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all medications out of the reach of children."
      ],
      "overdosage": [
        "In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years and over Dissolve 2 tablets under tongue every 4 hours until relieved. Children 6 years to under 12 years Dissolve 1 tablet under tongue every 4 hours until relieved."
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children   12 years and over </td><td>Dissolve 2 tablets under tongue every 4 hours until relieved.</td></tr><tr><td>Children 6 years   to under 12 years </td><td>Dissolve 1 tablet under tongue every 4 hours until relieved.</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Acacia Gum, Lactose."
      ],
      "questions": [
        "Questions or comments? (800) 624-9659"
      ],
      "recent_major_changes": [
        "Indications and Usage (Uses) Updated to  Reduces the duration and severity of common cold symptoms  Temporarily relieves symptoms of common cold, including:  sneezing  runny nose  congestion  cough  sore throat  headache  watery eyes  fever  chills",
        "Dosage and Administration Directions Adults and children 12 years and over Dissolve 2 tablets under tongue every 4 hours until relieved. Children 6 years to under 12 years Dissolve 1 tablet under tongue every 4 hours until relieved."
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL- PRINCIPAL DISPLAY PANEL HOMEOPATHIC NDC 54973-3010-1 AGES 6+ SINCE 1903 Hyland's Cold Tablets with Zinc* SHORTENS COLDS MULTI - SYMPTOM RELIEF Relieves Runny Nose, Congestion, Sore Throat, Cough, Sneezing, Headache and Fever Free of Dyes and Preservatives Non-Drowsy 50 QUICK-DISSOLVING TABLETS NATURAL RELIEF *SEE NOTE ON SIDE PANEL BELOW DRUGS FACTS Carton"
      ],
      "set_id": "120c1c96-dd70-4d54-e054-00144ff8d46c",
      "id": "2b382a01-d3ae-775d-e063-6394a90a6916",
      "effective_time": "20250108",
      "version": "8",
      "openfda": {
        "brand_name": [
          "COLD"
        ],
        "generic_name": [
          "ACONITUM NAPELLUS, ALLIUM CEPA, GELSEMIUM SEMP., ZINCUM GLUCONICUM"
        ],
        "manufacturer_name": [
          "Hyland's Inc."
        ],
        "product_ndc": [
          "54973-3010"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACONITUM NAPELLUS",
          "GELSEMIUM SEMPERVIRENS ROOT",
          "ONION",
          "ZINC GLUCONATE"
        ],
        "spl_id": [
          "2b382a01-d3ae-775d-e063-6394a90a6916"
        ],
        "spl_set_id": [
          "120c1c96-dd70-4d54-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "54973-3010-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0354973301016"
        ],
        "nui": [
          "N0000185371",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0022575"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Vegetable Proteins [CS]"
        ],
        "unii": [
          "U0NQ8555JD",
          "639KR60Q1Q",
          "492225Q21H",
          "U6WSN5SQ1Z"
        ]
      }
    }
  ]
}