{
    "spl_product_data_elements": [
        "Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE VITAMIN A ACETATE VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE LEVOMEFOLIC ACID LEVOMEFOLIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN MAGNESIUM OXIDE MAGNESIUM CATION CUPRIC SULFATE CUPRIC CATION SODIUM FLUORIDE FLUORIDE ION GRAPE CITRIC ACID MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SUCRALOSE SUCROSE STEARIC ACID 103 Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE VITAMIN A ACETATE VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE LEVOMEFOLIC ACID LEVOMEFOLIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN MAGNESIUM OXIDE MAGNESIUM CATION CUPRIC SULFATE CUPRIC CATION SODIUM FLUORIDE FLUORIDE ION GRAPE CITRIC ACID MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SUCRALOSE SUCROSE STEARIC ACID 104 Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE VITAMIN A ACETATE VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE LEVOMEFOLIC ACID LEVOMEFOLIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN MAGNESIUM OXIDE MAGNESIUM CATION CUPRIC SULFATE CUPRIC CATION SODIUM FLUORIDE FLUORIDE ION GRAPE CITRIC ACID MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SUCRALOSE SUCROSE STEARIC ACID 105"
    ],
    "spl_unclassified_section": [
        "Supplement Facts Serving Size: 1 Tablet Servings per Container: 30 Amount per Serving % Daily Value %Daily Value for Adults and Children 4 or more years of age Vitamin A (as Acetate) 1,200 IU 24% Vitamin C (as Ascorbic Acid) 60 mg 100% Vitamin D3 (as Cholecalciferol) 400 IU 100% Vitamin E (as DL-Alpha Tocopheryl Acetate) 15 IU 50% Thiamin (as Thiamine HCl, Vitamin B1) 1.2 mg 80% Riboflavin (Vitamin B2) 1.3 mg 76% Niacin (as Niacinamide) 5 mg 25% Vitamin B6 (as Pyridoxine HCl) 1.5 mg 75% Folate (as 200 mcg Quatrefolic\u00ae ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 108 mcg of Folic Acid), and 100 mcg of folic acid) 208 mcg 52% Vitamin B12 (as Cyanocobalamin) 4 mcg 67% Magnesium (as Magnesium Oxide) 15 mg 4% Copper (as Cupric Sulfate) 1 mg 50% Fluoride (as Sodium Fluoride) 0.5 mg Daily Value not established Other Ingredients: Citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, natural grape flavor, silicon dioxide, stearic acid, sucralose, sucrose and xylitol.",
        "TAMPER EVIDENT Do not use if seal is broken or missing.",
        "Quatrefolic\u00ae is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1 Manufactured for: Carwin Pharmaceutical Associates, LLC Hazlet, NJ 07730 www.carwinpharma.com Made in Canada Rev. 4/16"
    ],
    "spl_unclassified_section_table": [
        "<table width=\"60%\"><col width=\"65%\" align=\"left\" valign=\"top\"/><col width=\"15%\" align=\"center\" valign=\"top\"/><col width=\"20%\" align=\"center\" valign=\"top\"/><thead><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" colspan=\"3\">Supplement Facts</th></tr><tr styleCode=\"Botrule\"><th styleCode=\"Lrule Rrule\" colspan=\"3\">Serving Size: 1 Tablet Servings per Container: 30</th></tr><tr><th styleCode=\"Lrule\"/><th>Amount per Serving</th><th styleCode=\"Rrule\">% Daily Value<footnote ID=\"f1\">%Daily Value for Adults and Children 4 or more years of age</footnote></th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin A (as Acetate)</td><td>1,200 IU</td><td styleCode=\"Rrule\">24%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin C (as Ascorbic Acid)</td><td>60 mg</td><td styleCode=\"Rrule\">100%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin D3 (as Cholecalciferol)</td><td>400 IU</td><td styleCode=\"Rrule\">100%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin E (as DL-Alpha Tocopheryl Acetate)</td><td>15 IU</td><td styleCode=\"Rrule\">50%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Thiamin (as Thiamine HCl, Vitamin B1)</td><td>1.2 mg</td><td styleCode=\"Rrule\">80%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Riboflavin (Vitamin B2)</td><td>1.3 mg</td><td styleCode=\"Rrule\">76%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Niacin (as Niacinamide)</td><td>5 mg</td><td styleCode=\"Rrule\">25%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin B6 (as Pyridoxine HCl)</td><td>1.5 mg</td><td styleCode=\"Rrule\">75%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Folate (as 200 mcg Quatrefolic&#xAE; ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 108 mcg of Folic Acid), and 100 mcg of folic acid)</td><td>208 mcg</td><td styleCode=\"Rrule\">52%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Vitamin B12 (as Cyanocobalamin)</td><td>4 mcg</td><td styleCode=\"Rrule\">67%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Magnesium (as Magnesium Oxide)</td><td>15 mg</td><td styleCode=\"Rrule\">4%</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule\">Copper (as Cupric Sulfate)</td><td>1 mg</td><td styleCode=\"Rrule\">50%</td></tr><tr><td styleCode=\"Lrule\">Fluoride (as Sodium Fluoride)</td><td>0.5 mg</td><td styleCode=\"Rrule\"><footnote ID=\"f2\">Daily Value not established</footnote></td></tr></tbody></table>"
    ],
    "indications_and_usage": [
        "INDICATIONS AND USAGE Quflora\u2122 Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals."
    ],
    "contraindications": [
        "CONTRAINDICATIONS Quflora\u2122 Pediatric Chewable Tablets with 0.5 mg Fluoride should not be used by patients with a known history of hypersensitivity to any of the listed ingredients."
    ],
    "precautions": [
        "PRECAUTIONS General The suggested dose should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Your healthcare practitioner can prescribe the correct dosage. Folic Acid Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."
    ],
    "general_precautions": [
        "General The suggested dose should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Your healthcare practitioner can prescribe the correct dosage."
    ],
    "adverse_reactions": [
        "ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported. Call your doctor for medical advice about side effects. You may report side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011."
    ],
    "warnings": [
        "WARNINGS Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately. This product should be chewed and is not recommended for children under age 4."
    ],
    "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION One tablet daily or as prescribed by your healthcare practitioner. Each tablet contains 0.5 mg fluoride ion (F) from 1.1 mg sodium fluoride (NaF)."
    ],
    "description": [
        "DESCRIPTION Quflora\u2122 Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted \"104\"."
    ],
    "how_supplied": [
        "HOW SUPPLIED Quflora\u2122 Pediatric Chewable Tablets with 0.5 mg Fluoride available in child-resistant bottles of 30 (Product Code: 15370-104-30). Rx Only STORAGE Store at controlled room temperature 20\u00b0 C to 25\u00b0 C (68\u00b0 F to 77\u00b0 F), excursions permitted between 15\u00b0 C and 30\u00b0 C (59\u00b0 F and 86\u00b0 F). Protect from light, moisture and excessive heat. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN."
    ],
    "storage_and_handling": [
        "STORAGE Store at controlled room temperature 20\u00b0 C to 25\u00b0 C (68\u00b0 F to 77\u00b0 F), excursions permitted between 15\u00b0 C and 30\u00b0 C (59\u00b0 F and 86\u00b0 F). Protect from light, moisture and excessive heat. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN."
    ],
    "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label 15370-103-30 QU f LORA\u2122 PEDIATRIC Chewable Tablets Multivitamin with 0.25 mg Fluoride Each chewable tablet contains: 0.55 mg sodium fluoride, USP Rx Only \u2022 Grape Flavor 30 Tablets carwin PHARMACEUTICAL ASSOCIATES PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label",
        "PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label 15370-104-30 QU f LORA\u2122 PEDIATRIC Chewable Tablets Multivitamin with 0.5 mg Fluoride Each chewable tablet contains: 1.1 mg sodium fluoride, USP Rx Only \u2022 Grape Flavor 30 Tablets carwin PHARMACEUTICAL ASSOCIATES PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label",
        "PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label 15370-105-30 QU f LORA\u2122 PEDIATRIC Chewable Tablets Multivitamin with 1 mg Fluoride Each chewable tablet contains: 2.2 mg sodium fluoride, USP Rx Only \u2022 Grape Flavor 30 Tablets carwin PHARMACEUTICAL ASSOCIATES PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label"
    ],
    "set_id": "b8e08798-d8bb-4616-996b-a2c07a5d730a",
    "id": "0ad40f28-c81d-440a-8c07-d59f667487ed",
    "effective_time": "20240110",
    "version": "4",
    "openfda": {
        "brand_name": [
            "Quflora Pediatric"
        ],
        "generic_name": [
            "VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
            "CarWin Pharmaceutical Associates, LLC"
        ],
        "product_ndc": [
            "15370-103",
            "15370-104",
            "15370-105"
        ],
        "product_type": [
            "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
            "ORAL"
        ],
        "substance_name": [
            ".ALPHA.-TOCOPHEROL, DL-",
            "ASCORBIC ACID",
            "CHOLECALCIFEROL",
            "CUPRIC SULFATE",
            "CYANOCOBALAMIN",
            "FOLIC ACID",
            "LEVOMEFOLIC ACID",
            "MAGNESIUM OXIDE",
            "NIACINAMIDE",
            "PYRIDOXINE HYDROCHLORIDE",
            "RIBOFLAVIN",
            "SODIUM FLUORIDE",
            "THIAMINE HYDROCHLORIDE",
            "VITAMIN A ACETATE"
        ],
        "spl_id": [
            "0ad40f28-c81d-440a-8c07-d59f667487ed"
        ],
        "spl_set_id": [
            "b8e08798-d8bb-4616-996b-a2c07a5d730a"
        ],
        "package_ndc": [
            "15370-103-30",
            "15370-104-30",
            "15370-105-30"
        ],
        "is_original_packager": [
            true
        ],
        "nui": [
            "N0000178369",
            "M0008658",
            "M0022797",
            "N0000175952",
            "N0000193618",
            "M0001797",
            "M0022794",
            "N0000175951"
        ],
        "pharm_class_epc": [
            "Folate Analog [EPC]",
            "Vitamin D [EPC]",
            "Vitamin C [EPC]",
            "Vitamin B12 [EPC]"
        ],
        "pharm_class_cs": [
            "Folic Acid [CS]",
            "Vitamin D [CS]",
            "Ascorbic Acid [CS]",
            "Vitamin B 12 [CS]"
        ],
        "unii": [
            "8S95DH25XC",
            "TLM2976OFR",
            "68Y4CF58BV",
            "M572600E5P",
            "LRX7AJ16DT",
            "3A3U0GI71G",
            "3LE3D9D6OY",
            "935E97BOY8",
            "25X51I8RD4",
            "8ZYQ1474W7",
            "1C6V77QF41",
            "PQ6CK8PD0R",
            "7QWA1RIO01",
            "P6YC3EG204"
        ]
    }
}