{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "MEDIQUE Diamode Loperamide Hydrochloride ANHYDROUS LACTOSE CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM green Caplet 123 MEDIQUE Diamode Loperamide Hydrochloride ANHYDROUS LACTOSE CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM green Caplet 123 Private Label Distributor Loperamide HCl 2 mg LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSPOVIDONE D&C YELLOW NO. 10 POWDERED CELLULOSE STARCH, CORN FD&C BLUE NO. 1 CROSCARMELLOSE SODIUM ANHYDROUS LACTOSE MAGNESIUM STEARATE 123 Caplet"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information store between 68º - 77ºF (20º - 25ºC) tamper-evident sealed packets do not use any opened or torn packet"
      ],
      "active_ingredient": [
        "Active ingredient (in each caplet) Loperamide Hydrochloride 2mg"
      ],
      "purpose": [
        "Purpose Antidiarrheal"
      ],
      "indications_and_usage": [
        "Uses Controls the 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 HCl Do not use if you have bloody or black stool Ask a doctor before use if you have a fever mucus in stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics When using this product tiredness, drowsiness or dizziness may occur be careful when driving or operating machinery Stop use and ask a doctor if symptoms get worse diarrhea lasts more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If you are pregnant or breast feeding , ask a health professional before use. Keep this and all drugs out of the reach of children . In case of accidental overdose, contact a physician or Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use if you have bloody or black stool"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a fever mucus in stool a history of liver disease"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking antibiotics"
      ],
      "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 more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "If you are pregnant or breast feeding , ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all drugs out of the reach of children . In case of accidental overdose, contact a physician or Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours. Children under 12 years: Do not give to children under 12 years of age."
      ],
      "inactive_ingredient": [
        "Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10, FD&C Blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch"
      ],
      "questions": [
        "Questions or comments? 1-800-634-7680"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - 200R Medique Diamode Label Medique ® Diamode Controls the Symptoms of Diarrhea Pull to Open THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN ✓Anti-diarrheal • Loperamide HCl 2 mg 24 Caplets (24 x 1) Tamper Evident Unit Dose Packets 200R Diamode 20064 OHM 3-5-25 200R Diamode 20064 Gran 3-5-25",
        "Private Label Distributor Physicians Care Anti-Diarrheal Physicians Care® Anti-Diarrheal Controls Symptoms of Diarrhea Loperamide Hydrochloride 2 mg Pull To Open Easy to Swallow COATED CAPLETS Compare Active ingredient to: Imodium AD Registered Trademark of McNeil Consumer & Specialty Pharmaceuticals Tamper-Evident Unit Dose Packets Physicians Care® Registered Trademark of ACME UNITED Corporation 50 PACKETS (1 Caplet 2 Mg Each) PC Anti-Diarrheal",
        "Private Label Distributor Medex Anti-Diarrheal Relief Principal Display Panel Compare to the Active Ingredients in Imodium® A-D This box contains a generic product called Diamode Anti-Diarrheal Relief 20 Packets of 2 Tablets Remove This Panel Read Drug Facts and Instructions on Packet Anti-Diarrheal Relief"
      ],
      "set_id": "069e7979-a223-4819-b6cf-ea2731bf156b",
      "id": "441e7620-28e5-8cc5-e063-6394a90a2a72",
      "effective_time": "20251201",
      "version": "22",
      "openfda": {
        "application_number": [
          "ANDA074091"
        ],
        "brand_name": [
          "Private Label Distributor",
          "MEDIQUE Diamode"
        ],
        "generic_name": [
          "LOPERAMIDE HCL 2 MG",
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Unifirst First Aid Corporation"
        ],
        "product_ndc": [
          "47682-021",
          "47682-400",
          "47682-200"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "rxcui": [
          "978010",
          "978012"
        ],
        "spl_id": [
          "441e7620-28e5-8cc5-e063-6394a90a2a72"
        ],
        "spl_set_id": [
          "069e7979-a223-4819-b6cf-ea2731bf156b"
        ],
        "package_ndc": [
          "47682-400-46",
          "47682-400-69",
          "47682-400-64",
          "47682-200-69",
          "47682-200-50",
          "47682-200-46",
          "47682-200-33",
          "47682-200-64",
          "47682-021-50",
          "47682-021-25",
          "47682-021-30",
          "47682-021-75"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347682200640"
        ],
        "unii": [
          "77TI35393C"
        ]
      }
    }
  ]
}