{
  "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": "2026-10-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Ferrous Sulfate Ferrous Sulfate CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE FERROUS SULFATE FERROUS CATION"
      ],
      "spl_unclassified_section": [
        "SAVE CARTON FOR COMPLETE PRODUCT INFORMATION Supplement Facts % Daily Value Iron (as ferrous sulfate) 65 mg 360%"
      ],
      "spl_unclassified_section_table": [
        "<table frame=\"void\" width=\"830\"><caption>Supplement Facts</caption><thead><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"/><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><content styleCode=\"bold\">% Daily Value</content></td></tr></thead><tbody><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">Iron (as ferrous sulfate) 65 mg</td><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">360%</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "SUGGESTED USE:"
      ],
      "purpose": [
        "Adults: One (1) tablet daily, preferably after meals or as directed by the doctor. Children: As directed by the doctor."
      ],
      "active_ingredient": [
        "EACH TABLET CONTAINS: % U.S. RDA* Elemental Iron 65 mg (Equivalent to 325 mg of Ferrous Sulfate) 60 *U.S. Recommended Daily Allowance"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: croscarmellose sodium, dicalcium phosphate, FD&C red #40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide"
      ],
      "boxed_warning": [
        "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately."
      ],
      "warnings": [
        "WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product."
      ],
      "dosage_and_administration": [
        "DRUG INTERACTION PRECAUTION: Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other."
      ],
      "keep_out_of_reach_of_children": [
        "OTHER INFORMATION: Each tablet contains: calcium 20 mg (2% Daily value) Store in a dry place at controlled room temperature at 15°-30°C (59°-86°F). Do not expose to excessive heat or moisture."
      ],
      "questions": [
        "QUESTIONS OR COMMENTS? call 804-270-4498 , 8:30 am - 4:30 pm ET, Monday – Friday TAMPER EVIDENT: DO NOT USE IF A BLISTER PACKAGE UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING *Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark FEOSOL®. Distributed by: Richmond Pharmaceuticals, Inc., Richmond, VA 23233, USA CR1210 Principle Display Panel NDC 54738-963-13 Compare to Active Ingredient in Feosol ®* Ferrous Sulfate Tablets 325 mg (5 gr) Red Iron Supplement 100 Tablets (25x4) UNIT DOSE Richmond Pharmaceuticals, Inc. Richmond, VA 23233"
      ],
      "questions_table": [
        "<table frame=\"void\" width=\"590\"><tbody><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><content styleCode=\"bold\">TAMPER EVIDENT: DO NOT USE IF A BLISTER PACKAGE UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING</content></td></tr></tbody></table>"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 39803ffc-figure-01"
      ],
      "set_id": "5514d582-19b5-4f1e-b794-f790afb8211c",
      "id": "2a327df7-e75d-8130-e063-6294a90a6e83",
      "effective_time": "20241226",
      "version": "3",
      "openfda": {
        "brand_name": [
          "Ferrous Sulfate"
        ],
        "generic_name": [
          "FERROUS SULFATE"
        ],
        "manufacturer_name": [
          "Richmond Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "54738-963"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FERROUS SULFATE"
        ],
        "rxcui": [
          "310325"
        ],
        "spl_id": [
          "2a327df7-e75d-8130-e063-6294a90a6e83"
        ],
        "spl_set_id": [
          "5514d582-19b5-4f1e-b794-f790afb8211c"
        ],
        "package_ndc": [
          "54738-963-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0054738963137"
        ],
        "unii": [
          "39R4TAN1VT"
        ]
      }
    }
  ]
}