OB Complete One
OB Complete™ One
FULL PRESCRIBING INFORMATION: CONTENTS*
- INDICATIONS
- OB COMPLETE ONE CONTRAINDICATIONS
- PRECAUTIONS
- DRUG INTERACTIONS
- OB COMPLETE ONE ADVERSE REACTIONS
- OB COMPLETE ONE DESCRIPTION
- OB COMPLETE ONE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
FULL PRESCRIBING INFORMATION
PRESCRIBING INFORMATION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Softgel Servings per Box:30 |
For Pregnant and Lactating Women | |
| Amount per Serving | % Daily Value | |
| Purified Fish Oil | 476 mg |
 |
| DHA | 300 mg |
|
| Other Omegas (as EPA) | 40 mg |
|
| Vitamin C (Calcium Ascorbate) | 70 mg | 117% |
| Vitamin D3 (Cholecalciferol) | 1,200 IU | 300% |
| Vitamin E (d-Alpha Tocopheryl Acetate) | 30 IU | 100% |
| Vitamin B1 (Thiamine Mononitrate) | 2 mg | 118% |
| Vitamin B2 (Riboflavin) | 4 mg | 200% |
| Vitamin B3 (Niacinamide) | 10 mg | 50% |
| Vitamin B6 (Pyridoxine HCl) | 30 mg | 1200% |
| Folate (Folic Acid) | 1 mg | 125% |
| Vitamin B12 (Cyanocobalamin) | 50 mcg | 625% |
| Biotin | 200 mcg | 67% |
| Calcium Threonate | 5 mg | <1% |
| Calcium (as DimaCal® di-Calcium Malate) |
25 mg | 2% |
| Calcium (Calcium Carbonate) | 25 mg | 2% |
| Ferronyl Carbonyl Iron (Elemental Iron) | 40 mg | 222% |
| Sumalate® U.S. Pat. No. 6,716,814; U.S. Pat. No. 5,516,925; 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 |
10 mg | 57% |
| Iodine (Potassium Iodide) | 150 mcg | 100% |
| Magnesium (Magnesium Oxide) | 25 mg | 6% |
| Zinc (Zinc Oxide) | 15 mg | 100% |
| Copper(Cupric Sulfate) | 1 mg | 50% |
Other Ingredients
Yellow Bees Wax, Soybean Oil, Natural Creamy Orange Flavor, Lecithin, Gelatin, Purified Water, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Blue #1.
THIS PRODUCT CONTAINS SOYBEAN OIL AND FISH OIL
INDICATIONS
OB Complete™ One is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.
OB COMPLETE ONE CONTRAINDICATIONS
OB Complete™ One should not be used by patients with a known hypersensitivity to any of the listed ingredients including fish and fish oils.
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
OB Complete™ One softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.
OB COMPLETE ONE 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.
| 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. |
OB COMPLETE ONE DESCRIPTION
OB Complete™ One is an oblong-shaped purple softgel, imprinted "VP044".
OB COMPLETE ONE DOSAGE AND ADMINISTRATION
One softgel daily or as prescribed by a physician.
HOW SUPPLIED
OB Complete™ One softgels is available in carton unit dose pack of 30 (3 child resistant blister cards of 10 softgels per card.) 68025-044-30
STORAGE
Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light, moisture and excessive heat.
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.
Rx Only.
Manufactured for: Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872
Rev. 09/12
PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
Provides
Complete
Nutrition
For You
and Your
Baby Before,
During
and After
Pregnancy
OB
COMPLETE™
One
One Softgel Daily
- 476 mg Purified Fish Oil
-
- 300 mg DHA -
- 40 mg Other Omegas (EPA)
-
- 1200 IU Vitamin D3
- 1 mg Folate
68025-044-30
Rx Only
VERTICAL
PHARMACEUTICALS, INC.
OB Complete OneFish Oil, Doconexent, Icosapent, Calcium Ascorbate, Cholecalciferol, .Alpha.-Tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Threonate, Calcium Malate, Calcium Carbonate, Iron, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Zinc Oxide, and Cupric Sulfate CAPSULE, LIQUID FILLED
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