Indications and uses
Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.
Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.
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).
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet Servings per Container: 30 | ||
| Amount per Serving | % Daily Value* | |
| 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® ((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 | † |
Other Ingredients: Citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, natural grape flavor, silicon dioxide, stearic acid, sucralose, sucrose and xylitol.
Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.
Quflora™ 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.
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 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.
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.
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.
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).
Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted "104".
Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride available in child-resistant bottles of 30 (Product Code: 15370-104-30).
Rx Only
Store at controlled room temperature 20° C to 25° C (68° F to 77° F), excursions permitted between 15° C and 30° C (59° F and 86° F). Protect from light, moisture and excessive heat.
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.
Do not use if seal is broken or missing.
Quatrefolic® 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
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| LEVOMEFOLIC ACID Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20230428 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| VITAMIN A Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15370-105-30 | 2024-01-11 | C162847 | 48780-1 | ba0f9c33-55e8-a910-e053-dadaa90a0b85 | Quflora™ Pediatric Chewable Tablets |
| 15370-105-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-55e8-a910-e053-dadaa90a0b85 | Quflora™ Pediatric Chewable Tablets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15370-103-30 | Quflora Pediatric | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 4 | |
| 15370-104-30 | Quflora Pediatric | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 4 | |
| 15370-105-30 | Quflora Pediatric | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15370-103 | 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) TABLET, CHEWABLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240112_b8e08798-d8bb-4616-996b-a2c07a5d730a.zip |
| 15370-104 | 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) TABLET, CHEWABLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240112_b8e08798-d8bb-4616-996b-a2c07a5d730a.zip |
| 15370-105 | 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) TABLET, CHEWABLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240112_b8e08798-d8bb-4616-996b-a2c07a5d730a.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15370-103-30 | EA - Each | 15370-103 | 8778b80c-2000-4aa9-ba93-8c1966fe5f5e | 1 | 2014-02-04 |
| 15370-104-30 | EA - Each | 15370-104 | d776c8a1-0b22-4a6c-9bf0-0581e6ed6cde | 1 | 2014-02-04 |
| 15370-105-30 | EA - Each | 15370-105 | 7751f97d-5058-4c7e-9bec-a1c6a40549dc | 1 | 2014-02-04 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE INGREDIENT | 7QWA1RIO01 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CUPRIC SULFATE | ACTIVE INGREDIENT | LRX7AJ16DT | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| LEVOMEFOLIC ACID | ACTIVE INGREDIENT | 8S95DH25XC | 1 | |
| MAGNESIUM OXIDE | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| THIAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | M572600E5P | 1 | |
| VITAMIN A ACETATE | ACTIVE INGREDIENT | 3LE3D9D6OY | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| LEVOMEFOLIC ACID | ACTIVE MOIETY | 8S95DH25XC | 1 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| VITAMIN A | ACTIVE MOIETY | 81G40H8B0T | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GRAPE | INACTIVE INGREDIENT | 6X543N684K | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 15370-103 | 15370-103-30 |
| 15370-104 | 15370-104-30 |
| 15370-105 | 15370-105-30 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | CarWin Pharmaceutical Associates, LLC | b8e08798-d8bb-4616-996b-a2c07a5d730a | 2024-01-10 | Warnings, Adverse reactions | 15370-103-30 15370-105-30 15370-104-30 15370-103 15370-105 15370-104 15370010530 15370010330 15370010430 0ad40f28-c81d-440a-8c07-d59f667487ed b8e08798-d8bb-4616-996b-a2c07a5d730a |
Adverse event summaries are temporarily unavailable. Other product information remains available.