Folcal DHA

Midlothian Laboratories

Folcal DHA Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• FOLCAL DHA DESCRIPTION
• INDICATIONS
• FOLCAL DHA CONTRAINDICATIONS
• WARNING
• PRECAUTION
• FOLCAL DHA ADVERSE REACTIONS
• CAUTION
• FOLCAL DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx only

Rx Prenatal Vitamin with DHA

• 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acids)
• Essential vitamins and minerals
• Gentle stool softener

FOLCAL DHA DESCRIPTION

Folcal DHA Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with DHA. Each softgel capsule is maroon in color, opaque, and imprinted with "ML 352" in white.

Inactive Ingredients: Fish Oil, Gelatin NF, Sorbitol Sorbitan Solution NF, Glycerin USP, USP Purified Water, Soybean Oil USP, Yellow Beeswax NF, Lecithin NF (Bleached), Ethyl Vanillin, Titanium Dioxide, FD&C Red#40, FD&C Blue#1, White Edible Ink

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.

FOLCAL DHA 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

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.

FOLCAL DHA 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.

FOLCAL DHA DOSAGE AND ADMINISTRATION

Before, during, and/or after pregnancy, one softgel capsule daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 softgel capsules (NDC 68308-352-30).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Dispense in a well-closed container with child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]

THIS PRODUCT CONTAINS SOY.

Manufactured for:

Midlothian
LABORATORIES

Rev. 10/10

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 68308-352-30
30 Capsules

Folcal DHA
Capsules

DESCRIPTION: Folcal DHA Capsules are a prescription
prenatal/postnatal multivitamin/mineral softgel capsule
with DHA. Each softgel capsule is maroon in color, opaque,
and imprinted with "ML 352" in white.

INACTIVE INGREDIENTS: Fish Oil, Gelatin NF, Sorbitol
Sorbitan Solution NF, Glycerin USP, USP Purified Water,
Soybean Oil USP, Yellow Beeswax NF, Lecithin NF
(Bleached), Ethyl Vanillin, Titanium Dioxide, FD&C Red#40,
FD&C Blue#1, White Edible Ink

Rx Only

Midlothian
LABORATORIES