NDC | 68025-068-30 |
Set ID | 3c4faee4-e0e5-475d-804c-64ce639f6c38 |
Category | DIETARY SUPPLEMENT |
Packager | Vertical Pharmaceuticals, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
-
HEALTH CLAIM
Supplement Facts Serving Size: 1 Softgel Capsule Servings per Box: 30 Amount per Serving % DV for Pregnant and Lactating Women OmEGGa DHA™* 200 mg † Vitamin C (Magnesium Ascorbate) 70 mg 117% Vitamin D3 (Cholecalciferol) 1000 IU 250% Vitamin E (d-Alpha Tocopherol) 20 IU 67% Vitamin B6 (Pyridoxine HCl) 26 mg 1040% Folate [as Folic Acid USP 838 mcg and Quatrefolic®* ((6S)-5 Methyltetrahydrofolic acid) 162 mcg, (equivalent to 300 mcg of (6S)-5 methyltetrahydrofolic acid), glucosamine salt)] 1 mg 125% Vitamin B12 (Cyanocobalamin) 12 mcg 150% Calcium (Calcium Carbonate) 15 mg 1% Iron (Ferronyl®) 27.5 mg 153% Iodine (Potassium Iodide) 150 mcg 100% Magnesium (Magnesium Ascorbate) 5 mg 1% Other ingredients: Rice Bran Oil, Gelatin, Glycerin, Water, Beeswax, Sunflower Lecithin, Calcium Phosphate, Mica,Titanium Dioxide, Ethyl Vanillin, Yellow #5, Red #40, Yellow #6 and Blue #1.
THIS PRODUCT CONTAINS SOYBEAN OIL AND EGG.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
-
PRECAUTIONS
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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
- DRUG INTERACTIONS
-
ADVERSE REACTIONS
Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
- WARNINGS
- DOSAGE AND ADMINISTRATION
- DESCRIPTION
- HOW SUPPLIED
- HEALTH CLAIM
- STORAGE
- HEALTH CLAIM
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Blister Pack Carton
-
INGREDIENTS AND APPEARANCE
OB COMPLETE GOLD
1-(c14-c18 esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, egg phospholipids, magnesium ascorbate, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, calcium carbonate, iron, and potassium iodide capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:68025-068 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: FF489C658A) (1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE - UNII:FF489C658A) 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE 21 mg 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE (UNII: D98P995V9A) (1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE - UNII:D98P995V9A) 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE 21 mg EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) (EGG PHOSPHOLIPIDS - UNII:1Z74184RGV) EGG PHOSPHOLIPIDS 158 mg MAGNESIUM ASCORBATE (UNII: 0N1G678593) (MAGNESIUM ASCORBATE - UNII:0N1G678593) ASCORBIC ACID 70 mg cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol 1000 [iU] .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 20 [iU] pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine 26 mg folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid 838 ug 5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (folic acid - UNII:935E97BOY8) folic acid 162 ug cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin 12 ug calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium cation 15 mg iron (UNII: E1UOL152H7) (iron - UNII:E1UOL152H7) iron 27.5 mg potassium iodide (UNII: 1C4QK22F9J) (iodide ion - UNII:09G4I6V86Q) iodide ion 150 ug Inactive Ingredients Ingredient Name Strength rice bran oil (UNII: LZO6K1506A) gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) yellow wax (UNII: 2ZA36H0S2V) lecithin, sunflower (UNII: 834K0WOS5G) calcium phosphate (UNII: 97Z1WI3NDX) mica (UNII: V8A1AW0880) titanium dioxide (UNII: 15FIX9V2JP) ethyl vanillin (UNII: YC9ST449YJ) FD&C yellow no. 5 (UNII: I753WB2F1M) FD&C red no. 40 (UNII: WZB9127XOA) FD&C yellow no. 6 (UNII: H77VEI93A8) FD&C blue no. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68025-068-30 3 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/04/2016 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 14 mm imprint Labeler - Vertical Pharmaceuticals, LLC (173169017)