Vitafol Ultra

Generic Name: prenatal supplement with DHA
Dosage Form: capsule, liquid filled

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.

Vitafol®-Ultra
Prenatal Supplement with DHA

Rx

COMPOSITION

Amount per Capsule:

VITAMINS AND MINERALS:
*
(providing 200 mg DHA (docosahexaenoic acid))
Vitamin A (as beta carotene) 1100 IU
Vitamin C (as ascorbic acid) 30 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
(as Folic acid USP 0.4 mg and L-methylfolate Calcium 0.6 mg, as Metafolin® CAS# 151533-22-1)
1 mg
Vitamin B12 (as cyanocobalamin) 12 mcg
Iron (as polysaccharide iron complex) 29 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 crypthecodinium cohnii, CAS# 1258273-84-5) 415 mg*

Other Ingredients

Gelatin (bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, Yellow Beeswax, USP Purified Water, Lecithin, FD&C Blue #1, Titanium Dioxide (color), Ethyl Vanillin. May contain: Corn Oil, dl-alpha tocopherol, High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate.

Contains: Soy.

USAGE

Vitafol®-Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol®-Ultra does not contain fish, fish oils, fish proteins or fish byproducts.

Contraindications

Vitafol®-Ultra 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 the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS

Vitafol®-Ultra contains soy and lactose and should be used with caution in patients with known sensitivity or allergy to soy or lactose.

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.

Drug Interactions

Medications for an overactive thyroid (antithyroid 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.

Adverse Reactions

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®-Ultra. 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

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

How is Vitafol Ultra Supplied

Vitafol®-Ultra is available as a dark blue, oval shaped softgel capsule imprinted "EV0093". Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), 0642-0093-30 and as professional samples, 0642-0093-01

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.

Rx

Manufactured for
EVERETT LABORATORIES, INC.
Chatham, NJ 07928

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

Vitafol® is a trademark of Everett Laboratories, Inc.
U.S. Patent No. 8,183,227

Life's DHA™ is a trademark of DSM.
U.S. Patent No. 7,163,811 and 7,824,892

Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany.
U.S. Patent No. 6,441,168B1; 5,997,915; 6,254,904; 6,808,725
and 7,674,490

(Rev.09/13)

PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Carton

0642-0093-30

Vitafol® Ultra

PRENATAL SUPPLEMENT WITH 200 mg DHA

METAFOLIN®

Unit Dose Pack
30 Softgel Capsules

DOES NOT CONTAIN
FISH OIL

life's DHA

Rx

U.S. PATENTED

VITAFOL   ULTRA
doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, .beta.-carotene, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc oxide, cupric oxide, potassium iodide, magnesium oxide, folic acid, and levomefolate calcium capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0093
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doconexent (Doconexent) Doconexent 200 mg
Niacinamide (Niacinamide) Niacinamide 15 mg
.Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol, DL-) .Alpha.-Tocopherol, DL- 20 [iU]
Cholecalciferol (Cholecalciferol) Cholecalciferol 1000 [iU]
.Beta.-Carotene (.Beta.-Carotene) .Beta.-Carotene 1100 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 30 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.6 mg
Riboflavin (Riboflavin) Riboflavin 1.8 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Iron (Iron) Iron 29 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Oxide (Cupric Cation) Cupric Cation 2 mg
Potassium Iodide (Iodide Ion) Iodide Ion 150 ug
Magnesium Oxide (Magnesium Cation) Magnesium Oxide 20 mg
Folic Acid (Folic Acid) Folic Acid 0.4 mg
Levomefolate Calcium (Levomefolic Acid) Levomefolate Calcium 0.6 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin  
Sorbitol  
Glycerin  
Water  
Yellow Wax  
Soybean Oil  
Lecithin, Soybean  
Titanium Dioxide  
FD&C Blue No. 1  
Ethyl Vanillin  
Sunflower Oil  
Tocopherol  
Ascorbyl Palmitate  
Corn Oil  
.Alpha.-Tocopherol, DL-  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code EV0093
Contains         
Packaging
# Item Code Package Description
1 NDC:0642-0093-30 5 BLISTER PACK in 1 BOX
1 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 NDC:0642-0093-01 1 BLISTER PACK in 1 BOX
2 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/23/2013
Labeler - Everett Laboratories, Inc. (071170534)
Revised: 10/2013
 
Everett Laboratories, Inc.
Hide
(web4)