{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Premixed saline packets Sodium chloride, Sodium bicarbonate SODIUM BICARBONATE BICARBONATE ION SODIUM CHLORIDE CHLORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Chloride USP 2300mg Sodium Bicarbonate USP 700mg"
      ],
      "purpose": [
        "Purpose Nasal Wash"
      ],
      "indications_and_usage": [
        "Uses Relieve Nasal Passages From: ■Nasal symptoms from sinusitis, cold, flu ■Nasal allergies, dryness and Hay fever ■Sneezing, runny nose, nasal stuffiness ■lPost nasal drip and nasal congestion ■Removes nasal irritants (dust, pollen, animal dander, smoke etc) ■Promotes nasal and sinus drainage l■Moisturizes dry nasal passages ■Helps reduce swelling of nasal membranes"
      ],
      "warnings": [
        "Warnings Do not use ■ if saline packet is open, torn, or expired. ■ with fully blocked nasal passages or during ear infection or blockage. ■ unfiltered tap water, unless it has been previously boiled for at least five minutes and then cooled to lukewarm or body temperature, as boiling sterilizes the water. Other choice are distilled, micro-filtered (through 0.2 micron), reverse osmosis filtered, or commercially bottled water. When using this product Wash hands before using Stop use and ask a doctor if discomfort or unrelieved symptoms occur. Keep out of reach of children."
      ],
      "do_not_use": [
        "Do not use ■ if saline packet is open, torn, or expired. ■ with fully blocked nasal passages or during ear infection or blockage. ■ unfiltered tap water, unless it has been previously boiled for at least five minutes and then cooled to lukewarm or body temperature, as boiling sterilizes the water. Other choice are distilled, micro-filtered (through 0.2 micron), reverse osmosis filtered, or commercially bottled water."
      ],
      "when_using": [
        "When using this product Wash hands before using"
      ],
      "stop_use": [
        "Stop use and ask a doctor if discomfort or unrelieved symptoms occur."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 4 years and over: use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed Children under 4 years: Consult a physician Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free. Isotonic solution 1 saline packet per 8 fl oz (240 ml) Hypertonic solution 2 saline packets per 8 fl oz (240 ml) An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body's salt level. It can be more comfortable for some initially than a stronger Hypertonic solution. A Hypertonic solution has a higher salt concentration, akin to ocean water's salt content."
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\" cellspacing=\"0\" width=\"730px\"><tbody><tr><td><paragraph>Adults and children 4 years and over:</paragraph></td><td><paragraph>use 1-2 packets per 8 fl oz (240ml) up to every 2 hours as needed</paragraph></td></tr><tr><td><paragraph>Children under 4 years:</paragraph></td><td><paragraph>Consult a physician</paragraph></td></tr><tr><td colspan=\"2\"><paragraph>Mixing one saline packet to 8 fl oz (240ml) of water creates an Isotonic saline solution (Hypertonic with 2 saline packets) that is PH balanced and preservative free.</paragraph></td></tr><tr><td><paragraph>Isotonic solution</paragraph></td><td><paragraph>1 saline packet per 8 fl oz (240 ml)</paragraph></td></tr><tr><td><paragraph>Hypertonic solution</paragraph></td><td><paragraph>2 saline packets per 8 fl oz (240 ml)</paragraph></td></tr><tr><td colspan=\"2\"><paragraph>An Isotonic solution has a gentle salt concentration of 9 mg of Sodium Chloride per ml of water, similar to your body&apos;s salt level. It can be more comfortable for some initially than a stronger Hypertonic solution.</paragraph><paragraph>A Hypertonic solution has a higher salt concentration, akin to ocean water&apos;s salt content.</paragraph></td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information Store in a cool and dry place."
      ],
      "inactive_ingredient": [
        "Inactive ingredients None"
      ],
      "package_label_principal_display_panel": [
        "Label 001-"
      ],
      "set_id": "0d11e07b-c137-6efc-e063-6394a90a6bba",
      "id": "2b42cc1e-2017-8753-e063-6394a90aad5f",
      "effective_time": "20250109",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Premixed saline packets"
        ],
        "generic_name": [
          "SODIUM CHLORIDE, SODIUM BICARBONATE"
        ],
        "manufacturer_name": [
          "Shenzhen Kerui lntl Trading Co., Ltd"
        ],
        "product_ndc": [
          "83879-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "SODIUM BICARBONATE",
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1542919"
        ],
        "spl_id": [
          "2b42cc1e-2017-8753-e063-6394a90aad5f"
        ],
        "spl_set_id": [
          "0d11e07b-c137-6efc-e063-6394a90a6bba"
        ],
        "package_ndc": [
          "83879-001-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO",
          "451W47IQ8X"
        ]
      }
    }
  ]
}