{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Acid Reducer Maximum Strength Famotidine 20mg FAMOTIDINE FAMOTIDINE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A TALC TITANIUM DIOXIDE TRIACETIN V;15"
      ],
      "active_ingredient": [
        "Active ingredient(s) Famotidine USP 20mg"
      ],
      "purpose": [
        "Purpose Acid reducer"
      ],
      "indications_and_usage": [
        "Use(s) relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages"
      ],
      "warnings": [
        "Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disea Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor before use if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disea"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs."
      ],
      "stop_use": [
        "Stop use and ask a doctor before use if your heartburn continues or worsens you need to take this product for more than 14 days"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding, 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 (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor"
      ],
      "spl_unclassified_section": [
        "Other information read the directions and warnings before use do not use if imprinted safety seal under cap is broken or missing store at 20°-25°C (68°-77°F) protect from moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin"
      ],
      "questions": [
        "Questions/Comments Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Carton Label Carton Label"
      ],
      "set_id": "0c85b203-3d09-4799-97a9-722ee207bbfb",
      "id": "39e5e058-6419-4d47-ab41-d051f58065a1",
      "effective_time": "20260320",
      "version": "6",
      "openfda": {
        "application_number": [
          "ANDA215822"
        ],
        "brand_name": [
          "Acid Reducer Maximum Strength"
        ],
        "generic_name": [
          "FAMOTIDINE 20MG"
        ],
        "manufacturer_name": [
          "Grocery Outlet"
        ],
        "product_ndc": [
          "85828-443"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "310273"
        ],
        "spl_id": [
          "39e5e058-6419-4d47-ab41-d051f58065a1"
        ],
        "spl_set_id": [
          "0c85b203-3d09-4799-97a9-722ee207bbfb"
        ],
        "package_ndc": [
          "85828-443-25"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "5QZO15J2Z8"
        ]
      }
    }
  ]
}