{
  "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": "2026-10-02",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE BUTYLATED HYDROXYANISOLE GELATIN TYPE B BOVINE (160 BLOOM) GLYCERIN GLYCERYL MONOCAPRYLATE FD&C BLUE NO. 1 POLYOXYL 40 HYDROGENATED CASTOR OIL WATER Pale blue to blue LO2"
      ],
      "active_ingredient": [
        "Active ingredient (in each capsule) Loperamide Hydrochloride USP, 2 mg"
      ],
      "purpose": [
        "Purpose Anti-diarrheal"
      ],
      "indications_and_usage": [
        "Use controls symptoms of diarrhea, including Travelers' Diarrhea"
      ],
      "warnings": [
        "Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride Heart alert: Taking more than directed can cause serious heart problems or death"
      ],
      "do_not_use": [
        "Do not use if you have bloody or black stool in children under 12 years of age"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have fever mucus in the stool a history of liver disease a history of abnormal heart rhythm"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs."
      ],
      "when_using": [
        "When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery."
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition."
      ],
      "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 (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea. not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours"
      ],
      "spl_unclassified_section": [
        "Other information store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light. do not use if carton or blister unit is open or torn avoid excessive heat above 40°C (104°F) see side panel for lot number and expiration date FDA approved dissolution test specifications differ from USP."
      ],
      "inactive_ingredient": [
        "Inactive ingredients butylated hydroxyanisole, gelatin, glycerin, glyceryl monocaprylate, neelicert FD&C Blue No.1, polyoxyl 40 hydrogenated castor oil, purified water"
      ],
      "questions": [
        "Questions or comments? call toll free 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (24 Softgels) Blister Carton Label AUROHEALTH NDC 58602-727-78 †Compare to the active ingredient in Imodium ® A-D Loperamide Hydrochloride Capsules USP, 2 mg (Soft Gelatin Capsules) Anti-Diarrheal Controls the symptoms of diarrhea Suitable for adults and children 12 years and over Actual Size 24 Softgels* *each liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP Figure1"
      ],
      "set_id": "f9a53a23-a8ea-4521-8f0b-1bc2a658ff68",
      "id": "fe72649e-b4ec-4aaa-9a99-b81104a37710",
      "effective_time": "20260828",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA220372"
        ],
        "brand_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurohealth LLC"
        ],
        "product_ndc": [
          "58602-727"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "rxcui": [
          "978006"
        ],
        "spl_id": [
          "fe72649e-b4ec-4aaa-9a99-b81104a37710"
        ],
        "spl_set_id": [
          "f9a53a23-a8ea-4521-8f0b-1bc2a658ff68"
        ],
        "package_ndc": [
          "58602-727-74",
          "58602-727-75",
          "58602-727-80",
          "58602-727-76",
          "58602-727-78",
          "58602-727-77"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "77TI35393C"
        ]
      }
    }
  ]
}