Folcal DHA

Generic Name: prenatal multi-vitamin and minerals
Dosage Form: capsule, gelatin coated

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.

Folcal DHA Capsules

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

Folcal DHA 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.

Folcal DHA Dosage and Administration

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

How is Folcal DHA Supplied

Bottles of 30 softgel capsules (NDC 68308-350-30).

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.]

Manufactured for:
Midlothian LABORATORIES

Rev. 12/09

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-350
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 25 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 170 [iU]
ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 30 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.24 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 30 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 55 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 265 mg
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) TRIBASIC CALCIUM PHOSPHATE 160 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
SOYBEAN OIL  
SODIUM BENZOATE  
SUNFLOWER OIL  
WATER  
ETHYL VANILLIN  
LECITHIN, SOYBEAN  
WAX, YELLOW  
TITANIUM DIOXIDE  
PALM KERNEL OIL  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
AMMONIA  
ISOPROPYL ALCOHOL  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
SHELLAC  
ALCOHOL  
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code ML;350
Contains         
Packaging
# Item Code Package Description
1 NDC:68308-350-30 30 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/11/2010
Labeler - Midlothian Laboratories (142122824)
Establishment
Name Address ID/FEI Operations
Tishcon Corporation 195342449 MANUFACTURE
Revised: 01/2010
 
Midlothian Laboratories
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