Vitafol Gummies
Product Overview
Brand: Exeltis USA
Barcode: 3 06420 12590 4
Net Contents: 90 Gummy(ies)
Serving Size (Overview): 3 Gummy(ies)
Product Type: Other Combinations [A1325]
Form: Gummy or Jelly [E0176]
Date Entered: Dec 18, 2021
Market Status: On Market
Suggested Use (Overview): Directions for use: During pregnancy; take 3 gummies once daily; or as directed by a physician.
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Calories | other | 24 | Calorie(s) | N/A | N/A | 3 Gummy(ies) |
| Total Carbohydrates | sugar | 5 | Gram(s) | N/A | Pregnant and Lactating | 3 Gummy(ies) |
| Sugar | sugar | 5 | Gram(s) | N/A | Pregnant and Lactating | 3 Gummy(ies) |
| Vitamin A | vitamin | 330 | mcg RAE | 14 | Pregnant and Lactating | 3 Gummy(ies) |
| Vitamin C | vitamin | 30 | mg | 50 | Pregnant and Lactating | 3 Gummy(ies) |
| Vitamin D | vitamin | 25 | mcg | 250 | Pregnant and Lactating | 3 Gummy(ies) |
| Vitamin E | vitamin | 6.75 | mg | 50 | Pregnant and Lactating | 3 Gummy(ies) |
| Niacin | vitamin | 15 | mg NE | 75 | Pregnant and Lactating | 3 Gummy(ies) |
| Vitamin B6 | vitamin | 2.5 | mg | 100 | Pregnant and Lactating | 3 Gummy(ies) |
| Folate | vitamin | 1700 | mcg DFE | 125 | Pregnant and Lactating | 3 Gummy(ies) |
| Vitamin B12 | vitamin | 8 | mcg | 100 | Pregnant and Lactating | 3 Gummy(ies) |
| Iron | mineral | 10 | mg | 56 | Pregnant and Lactating | 3 Gummy(ies) |
| Iodine | mineral | 150 | mcg | 100 | Pregnant and Lactating | 3 Gummy(ies) |
| Choline | vitamin | 10 | mg | N/A | Pregnant and Lactating | 3 Gummy(ies) |
| Omega-3 Fatty Acids | fatty acid | 104.5 | mg | N/A | Pregnant and Lactating | 3 Gummy(ies) |
| Docosahexaenoic Acid | fatty acid | 75 | mg | N/A | Pregnant and Lactating | 3 Gummy(ies) |
| Eicosapentaenoic Acid | fatty acid | 15.3 | mg | N/A | Pregnant and Lactating | 3 Gummy(ies) |
| Other Omega-3 Fatty Acids | fatty acid | 14.2 | mg | N/A | Pregnant and Lactating | 3 Gummy(ies) |
Other Ingredients
Glucose Syrup; Water; Gelatin; Lactic Acid; Citric Acid; Mixed Berry flavor; Mineral Oil; Carnauba Wax; Natural color; Masking Flavor
Label Statements
Precautions
- Contraindications: Vitafol Gummies is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g. inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies etc.) pyridoxine responsive anemia or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12). 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/precautions: This product is intended for use as directed by your healthcare provider. Please do not share with others. Contains soybean and fish oil (cod). Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain high blood pressure formation of kidney stones renal failure and increased risk of heart disease can occur. Iodine should be used with caution in patients with an overactive thyroid. Prolonged use of iron salts may produce iron storage disease. Folic acid especially in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day form all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.Do not use if inner seal is broken or missing. Do not exceed recommended dose. Keep out of the reach of children. Drug interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine fosphenytoin phenytoin phenobarbitol valproic acid. Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions. Information for patients: Patients should be counseled to disclose all medical conditions including use of all medications vitamins and supplements pregnancy and breast-feeding. Pediatric use: Not for pediatric use. Adverse reactions: Adverse reactions have been reported with specific vitamins and minerals but generally at doses higher than those in Vitafol Gummies. However allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments gastrointestinal complaints glucose abnormalities and visual problems.
Suggested Use
- Directions for use: During pregnancy take 3 gummies once daily or as directed by a physician.
Other
- How supplied: Vitafol Gummies is available as a coated berry shaped gummy. Available in bottle of 90 0642-0125-90 and as professional samples in bottle 0642-0125-04.Rx (30 days supply)
Product Specific Information
- Store at room temperature approximately 15 degrees; 30 degrees C (59 degrees; 86 degrees F) avoid excessive heat and moisture.
Formulation
- Made in Colombia. Prenatal vital nutrition with iron Usage: Vitafol Gummies is indicated to provide vitamin mineral and DHA supplementation throughout pregnancy.
Branding Statement(s)
- Copyright 2021 Exeltis USA Inc.Vitafol is a trademark of Exeltis USA Inc.U.S. patent pending
Statement of Identity
- Dietary Supplement
Associated Company Information & Roles
Exeltis USA Inc.
Florham Park,
NJ
07932
Roles for this Product:
- Distributor