{
  "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": [
        "CareOne Acid Reducer Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide FAMOTIDINE FAMOTIDINE CALCIUM CARBONATE CARBONATE ION CALCIUM CATION MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION ANHYDROUS LACTOSE ASPARTAME DEXTRATES FERRIC OXIDE RED GLYCERYL MONOSTEARATE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 POVIDONE, UNSPECIFIED TALC PEACH WITH WHITE SPECKLES L546"
      ],
      "active_ingredient": [
        "Active ingredients (in each chewable tablet) Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg"
      ],
      "purpose": [
        "Purposes Acid reducer Antacid"
      ],
      "indications_and_usage": [
        "Use relieves heartburn associated with acid indigestion and sour stomach"
      ],
      "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 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 a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days If pregnant or breast-feeding, 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 right away. (1-800-222-1222)"
      ],
      "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 pharmacist before use if you are taking a prescription drug. Antacids and 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 more 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. 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: • do not swallow tablet whole: chew completely • to relieve symptoms, chew 1 tablet before swallowing • do not use more than 2 chewable tablets in 24 hours • children under 12 years: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information • each tablet contains: calcium 330 mg; magnesium 80 mg • Phenylketonurics: Contains Phenylalanine 2 mg per tablet • read the directions and warnings before use • read the bottle. It contains important information. • store at 20-25˚C (68-77˚F) • protect from moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients anhydrous lactose, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc"
      ],
      "questions": [
        "Questions or comments? 1-800-719-9260"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel CAREone™ Compare to the active ingredient in Pepcid Complete® ACID REDUCER COMPLETE Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets (Chewable) Acid Reducer + Antacid Cool Mint Flavor Actual Size Just One Tablet! Relieves Heartburn Due to Acid Indigestion Dual-Action See New Warnings OUR PHARMACISTS RECOMMEND 25 CHEWABLE TABLETS 546-of-acid-reducer-complete.jpg"
      ],
      "set_id": "19045840-2d25-43af-8c92-f36c8b903b28",
      "id": "b11a1345-9256-4c37-8c48-24c68e193c80",
      "effective_time": "20250828",
      "version": "8",
      "openfda": {
        "application_number": [
          "ANDA077355"
        ],
        "brand_name": [
          "CareOne Acid Reducer Complete"
        ],
        "generic_name": [
          "FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE"
        ],
        "manufacturer_name": [
          "American Sales Company"
        ],
        "product_ndc": [
          "41520-617"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CALCIUM CARBONATE",
          "FAMOTIDINE",
          "MAGNESIUM HYDROXIDE"
        ],
        "rxcui": [
          "283641"
        ],
        "spl_id": [
          "b11a1345-9256-4c37-8c48-24c68e193c80"
        ],
        "spl_set_id": [
          "19045840-2d25-43af-8c92-f36c8b903b28"
        ],
        "package_ndc": [
          "41520-617-63"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "H0G9379FGK",
          "5QZO15J2Z8",
          "NBZ3QY004S"
        ]
      }
    }
  ]
}