FOLCAL DHA- ascorbic acid, cholecalciferol, alpha-tocopherol acetate, pyridoxine hydrochloride, folic acid, ferrous fumarate, docusate sodium, doconexent, and tribasic calcium phosphate capsule, gelatin coated 
Mayne Pharma 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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Folcal DHA Capsules

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

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.

Each softgel capsule contains:
Vitamin C (ascorbic acid, USP)28 mg
Calcium (tribasic calcium phosphate, NF)160 mg
Iron (ferrous fumarate, USP)27 mg
Vitamin D3 (cholecalciferol, USP)400 IU
Vitamin E (d-alpha tocopherol, USP)30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)25 mg
Folic Acid, USP1.25 mg
DHA (docosahexaenoic acid)300 mg
Docusate Sodium, USP55 mg

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.

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.

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

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68308-352
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID28 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE30 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.25 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM55 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION160 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
FISH OIL (UNII: XGF7L72M0F)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code ML;352
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68308-352-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201012/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/201012/31/2016
Labeler - Mayne Pharma Inc. (867220261)

Revised: 12/2017
 
Mayne Pharma Inc.