OB Complete Premier
OB Complete™ Premier
FULL PRESCRIBING INFORMATION: CONTENTS*
- OB COMPLETE PREMIER DESCRIPTION
- INDICATIONS
- OB COMPLETE PREMIER CONTRAINDICATIONS
- PRECAUTIONS
- DRUG INTERACTIONS
- OB COMPLETE PREMIER ADVERSE REACTIONS
- OB COMPLETE PREMIER DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
FULL PRESCRIBING INFORMATION
PRESCRIBING INFORMATION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet Servings Per Box: 30 |
For Pregnant and Lactating Women | |
| Amount per Serving | % Daily Value | |
| Vitamin A (Beta Carotene) | 2100 IU | 26% |
| Vitamin C (Calcium Ascorbate) | 120 mg | 200% |
| Vitamin D3 (Cholecalciferol) | 800 IU | 200% |
| Vitamin E (d-Alpha Tocopheryl Succinate) | 20 IU | 67% |
| Vitamin B1 (Thiamine Mononitrate) | 2 mg | 118% |
| Vitamin B2 (Riboflavin) | 3.4 mg | 170% |
| Vitamin B3 (Niacinamide) | 10 mg | 50% |
| Vitamin B6 (Pyridoxine HCl) | 10 mg | 400% |
| Folate | 1 mg | 125% |
| Vitamin B12 (Cyanocobalamin) | 15 mcg | 188% |
| Minerals | ||
| Calcium (as DimaCal® Di-Calcium Malate)* | 100 mg | 8% |
| Ferronyl Carbonyl Iron (Elemental Iron) | 30 mg | 167% |
| Sumalate®† (Elemental Iron) | 20 mg | 111% |
| Magnesium (as Di-Magnesium Malate)* | 15 mg | 3% |
| Zinc (as TRAACS® Zinc Glycinate Chelate) | 10 mg | 67% |
| Copper | 1 mg | 50% |
Other Ingredients: Microcrystalline Cellulose, Di Cal Phosphate, Croscarmellose Sodium, Hypromellose, Titanium Dioxide, Fumed Silica, Stearic Acid, Magnesium Stearate, Acacia, Polyethylene Glycol, Polyvinylpyrrolidone, Ethyl Cellulose, Talc, Polysorbate 80, Castor Oil, and FD&C Red #40 Lake.
OB COMPLETE PREMIER DESCRIPTION
OB Complete™ Premier is a pink tablet, imprinted "VPO43".
INDICATIONS
OB Complete™ Premier 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 PREMIER CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
| WARNING |
| Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. |
DRUG INTERACTIONS
OB Complete™ Premier tablets are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.
OB COMPLETE PREMIER 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.
OB COMPLETE PREMIER DOSAGE AND ADMINISTRATION
One tablet daily or as prescribed by a physician.
HOW SUPPLIED
OB Complete™ Premier is available in carton unit dose pack of 30 (3 child resistant blister cards of 10 tablets per card). 68025-043-30
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.
Call your doctor about side effects. You may report side effects by calling 877-95-VERTI (877-958-3784).
†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
U.S. Pat. No. 8,007,846
And patents pending (including: U.S. Pat. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028)
*DimaCal and TRAACS are registered trademarks of Albion Laboratories, Inc.
Malates covered by U.S. Patent 6,706,904, Chelate covered U.S. Patent 7,838,042; and patents pending.
Manufactured for: Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872
PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
Part of the
Complete
Family of Next
Generation
Prenatal
Nutrition.
For You and
Your Baby
Before, During,
and After
Pregnancy
NEW
OB
COMPLETE™
Premier
One Tablet Daily
- 1 mg Folate
- 800 IU Vitamin D3
- 100 mg Calcium
(as DimaCal®
di-calcium malate)*
68025-043-30
Rx Only
VERTICAL
PHARMACEUTICALS, INC.
OB Complete Premier.Beta.-Carotene, Calcium Ascorbate, Cholecalciferol, .Alpha.-Tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Malate, Iron, Ferrous Asparto Glycinate, Magnesium Malate, Zinc Glycinate, and Copper TABLET, COATED
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