{
  "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": 8
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Premier Value Cough Drops Menthol SUCROSE FD&C BLUE NO. 1 POTASSIUM CITRATE SUCRALOSE FD&C RED NO. 40 CITRIC ACID MONOHYDRATE EUCALYPTUS OIL CORN SYRUP LECITHIN, SOYBEAN WATER MENTHOL MENTHOL B"
      ],
      "active_ingredient": [
        "Active Ingredient(s) Menthol 5.4 mg"
      ],
      "purpose": [
        "Purpose Purposes cough suppressant, oral anesthetic"
      ],
      "indications_and_usage": [
        "Use temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat"
      ],
      "warnings": [
        "Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have: ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus)."
      ],
      "stop_use": [
        "Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions ■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. ■ children under 5 years: ask a doctor."
      ],
      "storage_and_handling": [
        "Other information ■ 10 calories per drop ■ contains: SOY."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Glucose syrup, sucralose, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, potassium citrate, sucrose, soy lecithin, water"
      ],
      "questions": [
        "Or, to report an adverse event, call 800-245-2898. Monday - Friday, 9 AM to APM EST"
      ],
      "package_label_principal_display_panel": [
        "Package Label - Principal Display Panel 30 Drops NDC: 68016-885-30 PV label"
      ],
      "set_id": "019211bf-dd4b-5f4c-e063-6294a90aacfb",
      "id": "468e78a5-7a98-6efb-e063-6394a90aba2b",
      "effective_time": "20251222",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Premier Value"
        ],
        "generic_name": [
          "COUGH DROPS MENTHOL"
        ],
        "manufacturer_name": [
          "Pharmacy Value Alliance LLC"
        ],
        "product_ndc": [
          "68016-885"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MENTHOL"
        ],
        "rxcui": [
          "485287"
        ],
        "spl_id": [
          "468e78a5-7a98-6efb-e063-6394a90aba2b"
        ],
        "spl_set_id": [
          "019211bf-dd4b-5f4c-e063-6294a90aacfb"
        ],
        "package_ndc": [
          "68016-885-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0840986037955"
        ],
        "unii": [
          "L7T10EIP3A"
        ]
      }
    }
  ]
}