| NDC | 68025-048-30 |
| Set ID | f2b02ab6-0d90-4a2e-87d4-06e65f27d9f6 |
| Category | DIETARY SUPPLEMENT |
| Packager | Vertical Pharmaceuticals Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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STATEMENT OF IDENTITY
SUPPLEMENT FACTS Serving Size: 1 Softgel Capsule
Servings Per Box: 30For Pregnant and
Lactating WomenAmount per Serving % Daily Value Purified Fish Oil * 400 mg † Docosahexaenoic Acid (DHA) 320 mg † Other Omegas (as EPA, ALA and Linoleic Acid) 40 mg † Vitamin B1 (Thiamine Mononitrate) 2 mg 118% Vitamin B2 (Riboflavin) 3.4 mg 170% Vitamin B6 (Pyridoxine HCl) 40 mg 1600% Vitamin B12 (Cyanocobalamin) 20 mcg 250% Folic Acid 1 mg 125% Vitamin D3 (Cholecalciferol) 1000 IU 250% Vitamin C (Calcium ascorbate and calcium threonate) 110 mg 183% Vitamin E 30 IU 100% Vitamin B3 (Niacin) 10 mg 50% Copper (Sulfate) 1 mg 50% Zinc (Zinc Oxide) 25 mg 167% Ferronyl Iron 40 mg 222% Sumalate®(Elemental Iron)‡ 10 mg 56% - INDICATIONS AND USAGE
- CONTRAINDICATIONS
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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.
- WARNINGS
- DRUG INTERACTIONS
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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.
- DOSAGE AND ADMINISTRATION
- DESCRIPTION
- HOW SUPPLIED
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STORAGE
Store at controlled room temperature 15°-30°C (59°-86°F) [See USP] Protect from light, moisture and excessive heat.
‡ Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah
U.S. Pat. No. 6,716,814; U.S. Pat. No. 5,516,925; and U.S. Pat. No. 8,007,846 and patents pending (including: U.S. Pat. Appl. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028)
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN
Rx Only
Call your doctor about side effects. You may report side effects by calling 877-95-VERTI (877-958-3784).
Manufactured for: Vertical Pharmaceuticals Inc.
Sayreville, NJ 08872
www.verticalpharma.comRev. 03/2013
- PRINCIPAL DISPLAY PANEL - 30 Softgel Carton
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INGREDIENTS AND APPEARANCE
OB COMPLETE 400
fish oil, doconexent, omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, calcium ascorbate, calcium threonate, .alpha.-tocopherol, d-, niacin, cupric sulfate anhydrous, zinc oxide, iron pentacarbonyl, and ferrous asparto glycinate capsule, liquid filledProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:68025-048 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fish Oil (UNII: XGF7L72M0F) (Fish Oil - UNII:XGF7L72M0F) Fish Oil 400 mg Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 320 mg Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids 40 mg Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 2 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 3.4 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 40 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 20 ug Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 1000 [iU] Calcium Ascorbate (UNII: 183E4W213W) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 100 mg Calcium Threonate (UNII: HBB4YPO93U) (Calcium cation - UNII:2M83C4R6ZB) Ascorbic Acid 10 mg .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 30 [iU] Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 10 mg Cupric Sulfate Anhydrous (UNII: KUW2Q3U1VV) (Cupric Cation - UNII:8CBV67279L) Cupric Cation 1 mg Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 25 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 40 mg Ferrous Asparto Glycinate (UNII: H7426RGB3L) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation 10 mg Inactive Ingredients Ingredient Name Strength Gelatin (UNII: 2G86QN327L) Water (UNII: 059QF0KO0R) Yellow Wax (UNII: 2ZA36H0S2V) Ethyl Vanillin (UNII: YC9ST449YJ) Glycerin (UNII: PDC6A3C0OX) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C Red No. 40 (UNII: WZB9127XOA) FD&C Blue No. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68025-048-30 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 10/26/2012 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 22 mm imprint Labeler - Vertical Pharmaceuticals Inc. (173169017)
