NDC Code(s) : 68308-167-30
Packager : Midlothian Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Folcaps Care Onecalcium ascorbate, calcium threonate, Cholecalciferol, ALPHA-TOCOPHERYL ACETATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CALCIUM CARBONATE, IRON, IODINE, MAGNESIUM, ZINC, DOCUSATE SODIUM, DOCONEXENT, ICOSAPENT, and LINOLENIC ACID CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68308-167
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
calcium ascorbate(UNII: 183E4W213W)
(calcium ascorbate - UNII:183E4W213W) 		calcium ascorbate24 mg
calcium threonate(UNII: HBB4YPO93U)
(calcium threonate - UNII:HBB4YPO93U) 		calcium threonate1 mg
Cholecalciferol(UNII: 1C6V77QF41)
(Cholecalciferol - UNII:1C6V77QF41) 		Cholecalciferol800 [iU]
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
(ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) 		ALPHA-TOCOPHEROL ACETATE15 [iU]
RIBOFLAVIN(UNII: TLM2976OFR)
(RIBOFLAVIN - UNII:TLM2976OFR) 		RIBOFLAVIN1.5 mg
NIACINAMIDE(UNII: 25X51I8RD4)
(NIACINAMIDE - UNII:25X51I8RD4) 		NIACINAMIDE10 mg
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE HYDROCHLORIDE50 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID1 mg
BIOTIN(UNII: 6SO6U10H04)
(BIOTIN - UNII:6SO6U10H04) 		BIOTIN300 mg
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM - UNII:SY7Q814VUP) 		CALCIUM CARBONATE100 mg
IRON(UNII: E1UOL152H7)
(IRON - UNII:E1UOL152H7) 		IRON27 mg
IODINE(UNII: 9679TC07X4)
(POTASSIUM CATION - UNII:295O53K152) 		IODINE150 ug
MAGNESIUM(UNII: I38ZP9992A)
(MAGNESIUM OXIDE - UNII:3A3U0GI71G) 		MAGNESIUM50 mg
ZINC(UNII: J41CSQ7QDS)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC5 mg
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
(DOCUSATE - UNII:M7P27195AG) 		DOCUSATE SODIUM50 mg
DOCONEXENT(UNII: ZAD9OKH9JC)
(DOCONEXENT - UNII:ZAD9OKH9JC) 		DOCONEXENT350 mg
ICOSAPENT(UNII: AAN7QOV9EA)
(ICOSAPENT - UNII:AAN7QOV9EA) 		ICOSAPENT100 mg
LINOLENIC ACID(UNII: 0RBV727H71)
(LINOLENIC ACID - UNII:0RBV727H71) 		LINOLENIC ACID50 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
SOYBEAN OIL(UNII: 241ATL177A)
FLAX SEED(UNII: 4110YT348C)
ETHYL VANILLIN(UNII: YC9ST449YJ)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
WAX, YELLOW(UNII: 2ZA36H0S2V)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 25 mm
Flavor Imprint Code ML;167
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68308-167-3030 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/01/2009

PRINCIPAL DISPLAY PANEL

NDC 68308-167-30
30 Capsules

Folcaps™
Care One

DESCRIPTION:
Folcaps™ Care One is a prenatal multivitamin/mineral
capsule with omega-3 fatty acids.

INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil,
flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium
dioxide, silicon dioxide, and FD&C Red No. 40.

Rx Only

Midlothian
LABORATORIES

Principal Display Panel - 30 Capsule Label