Vitafol ® Fe + Supplement Prenatal Supplement with 90 mg Iron, and Optional Stool Softener

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)

Available from:

Exeltis USA, Inc.

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" 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. Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat 40°C (104°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- 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
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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VITAFOL FE SUPPLEMENT
PRENATAL SUPPLEMENT WITH 90 MG IRON, AND OPTIONAL STOOL
SOFTENER
RX
PRENATAL SUPPLEMENT
COMPOSITION
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
mcg
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 (from crypthecodinium cohnii)
providing 200 mg DHA (docosahexaenoic acid)
415
mg
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
Chain Triglycerides.
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, 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