Label: VITAFOL GUMMIES- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, iodine, choline, doconexent, icosapent, and omega-3 fatty acids tablet, chewable
- NHRIC Code(s): 0642-0125-90, 0642-0125-04
- Packager: Exeltis USA, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated June 2, 2021
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- Official Label (Printer Friendly)
- HEALTH CLAIM
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COMPOSITION
Amount per daily dose (3 gummies)
VITAMINS AND MINERALS: Calories 24 Total Carbohydrates 5 g Sugars 5 g Vitamin A (as Vitamin A palmitate) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as d-alpha tocopheryl acetate) 6.75 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 8 mcg Iron (as ferric orthophosphate) 10 mg Iodine (as potassium iodide) 150 mcg Choline (as choline bitartrate) 10 mg Omega 3 fatty acid 104.5 mg Docosahexaenoic acid (DHA) 75 mg Eicosapentaenoic acid (EPA) 15.3 mg Other Omega 3 fatty acid 14.2 mg Other Ingredients: Sugar, glucose syrup, water, gelatin, lactic acid, citric acid, mixed berry flavor, Certicoat 580 (contains mineral oil and Carnauba wax), Natural Color and Masking flavor.
Contains soybean and fish oil (cod).
- USAGE
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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).
- WARNINGS
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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 from 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.
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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.
- DIRECTIONS FOR USE
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HOW SUPPLIED
Vitafol® Gummies is available as a coated berry shaped gummy. Available in bottle of 90, Item No. 0642-0125-90 and as professional samples, in bottle with 3 gummies, Item No. 0642-0125-04.
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349
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HEALTH CLAIM
Made in Colombia.
Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349www.exeltisUSA.com
©2021 Exeltis USA, Inc.These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Vitafol® is a trademark of Exeltis USA, Inc.
U.S. Patent PendingRev. April 2021
1250301-04 - PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
VITAFOL GUMMIES
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, iodine, choline, doconexent, icosapent, and omega-3 fatty acids tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:0642-0125 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 330 ug Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 30 mg Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D 25 ug .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 6.75 mg Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 15 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1700 ug Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 8 ug Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 10 mg Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 150 ug Choline (UNII: N91BDP6H0X) (Choline - UNII:N91BDP6H0X) Choline 10 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 75 mg Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent 15.3 mg Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids 14.2 mg Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Corn Syrup (UNII: 9G5L16BK6N) Water (UNII: 059QF0KO0R) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Lactic Acid, Unspecified Form (UNII: 33X04XA5AT) Citric Acid Monohydrate (UNII: 2968PHW8QP) Keracyanin (UNII: V0N2VMB4FV) Propylene Glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0642-0125-90 90 in 1 BOTTLE, PLASTIC 2 NHRIC:0642-0125-04 3 in 1 BOX, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 05/01/2016 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 20 mm flavor Labeler - Exeltis USA, Inc. (071170534)
