FOLTABS PRENATAL PLUS DHA- prenatal vitamins and minerals
Midlothian Laboratories, LLC
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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Foltabs™ Prenatal Plus DHA is a prescription prenatal/postnatal
multivitamin/mineral tablet and a gel capsule of an essential fatty acid. The prenatal
vitamin is a scored, white, oval multivitamin/mineral tablet. The tablet is debossed “ML
160” on one side and is blank on the other. The essential fatty acid DHA capsule is clear
and contains a light yellow semi-solid mixture.
Each prenatal tablet contains:
Vitamin C (Ascorbic acid) ................................................................... 120 mg
Calcium (Calcium citrate) ................................................................... 125 mg
Iron (Carbonyl iron, Ferrous gluconate) ............................................... 27 mg
Vitamin D3 (Cholecalciferol) ................................................................ 400 IU
Vitamin E (dl-alpha tocopheryl acetate) ................................................. 30 IU
Thiamin (Vitamin B1) ............................................................................. 3 mg
Riboflavin (Vitamin B2) ....................................................................... 3.4 mg
Niacinamide (Vitamin B3) .................................................................... 20 mg
Vitamin B6 (Pyridoxine HCl) ................................................................ 20 mg
Folic Acid ............................................................................................... 1 mg
Iodine (Potassium iodide) ................................................................. 150 mcg
Zinc (Zinc oxide) .................................................................................. 25 mg
Copper (Cupric sulfate) .......................................................................... 2 mg
Docusate Sodium ................................................................................. 50 mg
Each DHA gelatin capsule contains:
Docosahexaenoic Acid (DHA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mg
DHA is contained in the oil derived from a purified fish oil source.
Inactive Ingredients:
Microcrystalline cellulose, croscarmellose sodium,
silicon dioxide, magnesium stearate, polysorbate 80, stearic acid, talc,
povidone, polyethylene glycol, titanium dioxide, polyvinyl alcohol.
Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.
Foltabs™ Prenatal Plus DHA is a multivitamin/mineral prescription drug
indicated for use in improving the nutritional status of women prior to conception, throughout
pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
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 poison control center immediately.
Ingestion of more than 3 grams of omega-3 fatty acids per day has been
shown to have potential antithrombotic effects, including an increased bleeding time and
INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants
and in those known to have an inherited or acquired bleeding diathesis.
Folic acid alone is improper therapy in the treatment of pernicious anemia and
other megaloblastic anemias where vitamin B12 is deficient.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in
that hematologic remission can occur while neurological manifestations progress.
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
NOTICE: Contact with moisture can discolor or erode the tablet.
Allergic sensitization has been reported following both oral and
parenteral administration of folic acid. Caution should be exercised with patients with
known allergies to fish or fish byproducts.
FOLTABS PRENATAL PLUS DHA
prenatal vitamins and minerals kit |
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Labeler - Midlothian Laboratories, LLC (142122824) |