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

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
14-03-2023

Aktiv bestanddel:

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

Tilgængelig fra:

Exeltis USA, Inc.

INN (International Name):

Doconexent

Sammensætning:

Doconexent 200 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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).

Produkt oversigt:

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- 0093-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

Autorisation status:

unapproved drug other

Produktets egenskaber

                                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
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._
----------
0642-0093-30
VITAFOL
ULTRA
PRENATAL SUPPLEMENT WITH DHA
RX
COMPOSITION
Amount per Capsule:
VITAMINS AND MINERALS:
Vitamin A (as beta carotene)
330
mcg
RAE
Vitamin C (as ascorbic acid)
30 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
(680 mcg DFE from folic acid &
1020 mcg DFE from l-methylfolate
calcium)
1700
mcg
DFE
Vitamin B12 (as cyanocobalamin)
12 mcg
Iron (as polysaccharide iron
complex)
29 mg
150
®
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), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol,
Purified Water, Soy
Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl
Vanillin. Titanium
Dioxide (color). May contain: Sunflower Oil, Olive Oil.
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.*
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 contraindic
                                
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