{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Rolaids ACID DEFENSE Famotitine CROSCARMELLOSE SODIUM POLYVINYL ALCOHOL, UNSPECIFIED CARNAUBA WAX TALC FAMOTIDINE FAMOTIDINE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE L194"
      ],
      "spl_unclassified_section": [
        "Rolaids ACID DEFENSE Drug Facts",
        "TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS MISSING OR DAMAGED",
        "DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202"
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Famotidine 20 mg"
      ],
      "purpose": [
        "Purpose Acid reducer"
      ],
      "indications_and_usage": [
        "Uses 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 foods and beverages"
      ],
      "warnings": [
        "Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers"
      ],
      "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 have 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 disease"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharnacist 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 if your heartburn continues or worsens you need to take this product for mor than 14 days"
      ],
      "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."
      ],
      "overdosage": [
        "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tabelt with a glass of water 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"
      ],
      "other_safety_information": [
        "Other information read the directions and warnings before use keep the carton. It contains important information. store at 20º - 25ºC (68º - 77ºF) protect from moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? 1-833-372-2729"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH Rolaids ACID DEFENSE FAMOTIDINE TABLETS, 20MG ACID REDUCER JUST 1 TABLET! PREVENTS & RELIEVES HEARTBURN DUE TO ACID INDIGESTION 25 TABLETS 367"
      ],
      "set_id": "3bdbeabb-6b06-5468-e063-6394a90a03c9",
      "id": "4e3da807-1c29-8dd8-e063-6394a90ae5cb",
      "effective_time": "20260330",
      "version": "3",
      "openfda": {
        "application_number": [
          "ANDA077351"
        ],
        "brand_name": [
          "Rolaids ACID DEFENSE"
        ],
        "generic_name": [
          "FAMOTITINE"
        ],
        "manufacturer_name": [
          "The Procter & Gamble Manufacturing Company"
        ],
        "product_ndc": [
          "84126-367"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "310273"
        ],
        "spl_id": [
          "4e3da807-1c29-8dd8-e063-6394a90ae5cb"
        ],
        "spl_set_id": [
          "3bdbeabb-6b06-5468-e063-6394a90a03c9"
        ],
        "package_ndc": [
          "84126-367-25"
        ],
        "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"
        ]
      }
    }
  ]
}