FOLCAL DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, folic acid, ferrous fumarate, docusate sodium, doconexent and tribasic calcium phosphate capsule, gelatin coated
Midlothian Laboratories
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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Rx only
Rx Prenatal Vitamin with DHA
- 1.24 mg Folic Acid and 265 mg DHA (key omega-3 fatty acids)
- Essential vitamins and minerals
- Gentle stool softener
DESCRIPTION
Folcal DHA Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with DHA. Each softgel capsule is brown in color, opaque, and imprinted with "ML 350" in white.
| Each softgel capsule contains: | |
|---|---|
| Vitamin C (ascorbic acid, USP) | 25 mg |
| Calcium (tribasic calcium phosphate, NF) | 160 mg |
| Iron (ferrous fumarate, USP) | 30 mg |
| Vitamin D3 (cholecalciferol, USP) | 170 IU |
| Vitamin E (d-alpha tocopherol, USP) | 30 IU |
| Vitamin B6 (pyridoxine hydrochloride, USP) | 25 mg |
| Folic Acid, USP | 1.24 mg |
| DHA (docosahexaenoic acid) | 265 mg |
| Docusate Sodium, USP | 55 mg |
Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water, and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, titanium dioxide).
INDICATIONS
Folcal DHA Capsules are indicated to provide vitamin/mineral and DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folcal DHA may be useful in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS
Folcal DHA Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.
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 poison control center immediately.
WARNING
Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
PRECAUTION
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 1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
CAUTION
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
DOSAGE AND ADMINISTRATION
Before, during, and/or after pregnancy, one softgel capsule daily or as directed by a physician.
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
NDC 68308-350-30
30 Capsules
Folcal DHA
Capsules
DESCRIPTION: Folcal DHA Capsules are a prescription
prenatal/postnatal multivitamin/mineral softgel capsule
with DHA. Each softgel capsule is brown in color, opaque,
and imprinted with "ML 350" in white.
INACTIVE INGREDIENTS: Ethyl vanillin, FD&C blue #1,
FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin,
palm kernel oil, sodium benzoate, soybean oil, sunflower
oil, titanium dioxide, yellow beeswax, water, and white ink
(ammonium hydroxide, isopropyl alcohol, n-butyl alcohol,
propylene glycol, shellac glaze in SD-45 alcohol, titanium
dioxide).
Rx Only
Midlothian
LABORATORIES
| FOLCAL DHA
ascorbic acid, cholecalciferol, alpha-tocopherol acetate, pyridoxine hydrochloride, folic acid, ferrous fumarate, docusate sodium, doconexent, and tribasic calcium phosphate capsule, gelatin coated |
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| Labeler - Midlothian Laboratories (142122824) |