Label: VITAFOL FE PLUS- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iodine, iron, magnesium, zinc, copper, doconexent, and docusate sodium kit
- NDC Code(s): 0642-0096-30
- Packager: Exeltis USA, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated October 17, 2019
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- SPL UNCLASSIFIED SECTION
Each PURPLE softgel capsule contains:
Vitamin A (as beta carotene) 1100 IU Vitamin C (as ascorbic acid) 60 mg Vitamin D (as cholecalciferol) 1000 IU Vitamin E (as dl-alpha tocopheryl acetate) 20 IU Thiamin (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate 1 mg (as Folic acid USP 0.4 mg; as L-methylfolate calcium 0.6 mg) Vitamin B12 (as cyanocobalamin) 25 mg Iron (as polysaccharide iron complex) 90 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Algal oil blend (derived from Natural Algal Oil) 415 mg (*providing 200 mg DHA (docosahexaenoic acid))
Other Ingredients: Gelatin, Soybean Oil, Sorbitol, Glycerin, Yellow Beeswax, USP Purified Water, Lecithin, Titanium Dioxide (as colorant), FD&C Red #40, FD&C Blue #1, White Edible Ink.
Contains: Soy. May also contain: Corn Oil, DL alpha-tocopherol, Medium ChainTriglycerides.
Vitafol® Fe+ prenatal supplement 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 supplementation 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).
- BOXED WARNING (What is this?)
This product is intended for use as directed by your healthcare provider. Do not share with others. Vitafol® Fe+ must be used with caution in patients with known sensitivity or allergy to soy.
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.
Avoid Overdosage. Keep out of the reach of children.
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 levels in blood.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, 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.
INFORMATION FOR PATIENTS
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol® Fe+. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
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Ask a doctor before use if you have stomach pain, nausea, or vomiting; or a sudden change in bowel habits that lasts over 14 days.
Ask your doctor before use if you are breastfeeding.
Ask a doctor or pharmacist before use if you are presently taking mineral oil, or other laxative products.
Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product, as these could be signs of a serious condition.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- DIRECTIONS FOR USE
Vitafol® Fe+ is available as a purple, oval shaped softgel capsule imprinted "EX0096" and one white, oval shaped softgel capsule imprinted "50". Available in box of Unit-Dose pack of 30 (6 child resistant blister cards of 5+5 softgel capsules), Item No. 0642-0096-30 and as professional samples Item No. 0642-0096-01.
SPL UNCLASSIFIED SECTION
You should call your doctor for medical advice about adverse or unexpected reactions. To report to the company an adverse event or obtain product information, call 1-877-324-9349.
Exeltis USA, Inc.
Florham Park, NJ 07932
©2018 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.
Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany. U.S. Patent No. 6,441,168; 5,997,915; 6,254,904; 6,808,725, 7,172,778 and 7,674,490
Rev. November 2018
- PRINCIPAL DISPLAY PANEL - Kit Carton
INGREDIENTS AND APPEARANCE
VITAFOL FE PLUS
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iodine, iron, magnesium, zinc, copper, doconexent, and docusate sodium kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0096 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-0096-30 1 in 1 CARTON 10/01/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 BLISTER PACK 30 Part 2 6 BLISTER PACK 30 Part 1 of 2 VITAFOL FE PLUS PRENATAL SUPPLEMENT
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iodine, iron, magnesium, zinc, copper, and doconexent capsule, liquid filled
Product Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 1100 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D 1000 [iU] .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 20 [iU] Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.6 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.8 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 1 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 25 ug Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 150 ug Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 90 mg Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium 20 mg Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 25 mg Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 2 mg Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 200 mg Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Soybean Oil (UNII: 241ATL177A) Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) Yellow Wax (UNII: 2ZA36H0S2V) Water (UNII: 059QF0KO0R) Lecithin, Soybean (UNII: 1DI56QDM62) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C Red No. 40 (UNII: WZB9127XOA) FD&C Blue No. 1 (UNII: H3R47K3TBD) Corn Oil (UNII: 8470G57WFM) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Product Characteristics Color PURPLE Score no score Shape OVAL Size 17mm Flavor Imprint Code EX0096 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/01/2015 Part 2 of 2 VITAFOL FE PLUS STOOL SOFTENER SUPPLEMENT
docusate sodium capsule, liquid filled
Product Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 50 mg Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Titanium Dioxide (UNII: 15FIX9V2JP) Citric Acid Monohydrate (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score no score Shape OVAL Size 10mm Flavor Imprint Code 50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 10/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/01/2015 Labeler - Exeltis USA, Inc. (071170534)