VITAFOL FE PLUS- doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, beta carotene, ascorbic acid, thiami

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), R

Available from:

Exeltis USA, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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).

Product summary:

Vitafol ® Fe + is available as a purple, oval shaped softgel capsule imprinted "EX0096". Available in box of Unit-Dose pack of 30 (5 child resistant blister cards containing 6 softgel capsules) (0642-7473-30) and as professional samples (0642-7473-01). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat above 30°C (86°F), light and moisture. Please dispose of any unused capsules promptly, and properly.

Authorization status:

unapproved drug other

Summary of Product characteristics

VITAFOL FE PLUS- 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
EXELTIS USA, INC.
_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._
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0642-7473-30
VITAFOL FE SUPPLEMENT
PRENATAL SUPPLEMENT WITH 90 MG IRON
RX
COMPOSITION:
Each Vitafol
Fe+ softgel capsule contains:
Vitamin A (as beta carotene)
330 mcg
RAE
Vitamin C (as ascorbic acid)
60 mg
Vitamin D (as cholecalciferol)
25 mcg
Vitamin E (as dl-alpha tocopheryl acetate)
9 mg
Thiamin (Vitamin B1 as thiamine
mononitrate)
1.6 mg
Riboflavin (Vitamin B2)
1.8 mg
Niacin (as niacinamide)
15 mg NE
Vitamin B6 (as pyridoxine hydrochloride)
2.5 mg
Folate
1700 mcg
DFE
(680 mcg DFE from folic acid & 1020 mcg DFE from
l-methylfolate calcium)
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
Docosahexaenoic acid (DHA)
(from natural algal oil)
200 mg
®
+
®
OTHER INGREDIENTS:
Gelatin (Bovine), Soybean Oil, Glycerin, Yellow Beeswax, Sorbitol, Soy
Lecithin, Titanium
Dioxide (color), FD&C Red #40, FD&C Blue #1
CONTAINS: SOY
USAGE:
Vitafol
Fe
prenatal supplement provides vitamin, mineral and omega-3 fatty acid
supplementation throughout pregnancy, including individuals with known
allergies to
fish.* Vitafol
Fe
does not contain fish oils, fish proteins, or fish by-products.
CONTRAINDICATIONS:
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 wi