OB COMPLETE PREMIER- .beta.-carotene, calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron pentacarbonyl, ferrous asparto glycinate, magnesium malate, zinc glycinate and cupric glycinate tablet, coated 
Vertical Pharmaceuticals Inc.

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OB Complete™ Premier

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 IU26%
Vitamin C (Calcium Ascorbate)120 mg200%
Vitamin D3 (Cholecalciferol)800 IU200%
Vitamin E (d-Alpha Tocopheryl Succinate)20 IU67%
Vitamin B1 (Thiamine Mononitrate)2 mg118%
Vitamin B2 (Riboflavin)3.4 mg170%
Vitamin B3 (Niacinamide)10 mg50%
Vitamin B6 (Pyridoxine HCl)10 mg400%
Folate1 mg125%
Vitamin B12 (Cyanocobalamin)15 mcg188%
Minerals
Calcium (as DimaCal® Di-Calcium Malate)*100 mg8%
Ferronyl Carbonyl Iron (Elemental Iron)30 mg167%
Sumalate®† (Elemental Iron)20 mg111%
Magnesium (as Di-Magnesium Malate)*15 mg3%
Zinc (as TRAACS® Zinc Glycinate Chelate)10 mg67%
Copper1 mg50%

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.

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.

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.

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

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

68025-043-30
Rx Only

VERTICAL
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
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
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-043
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
.Beta.-Carotene (.Beta.-Carotene) .Beta.-Carotene2100 [iU]
Calcium Ascorbate (Ascorbic Acid) Ascorbic Acid120 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol800 [iU]
.Alpha.-Tocopherol Acetate, D- (.Alpha.-Tocopherol, D-) .Alpha.-Tocopherol, D-20 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine2 mg
Riboflavin (Riboflavin) Riboflavin3.4 mg
Niacinamide (Niacinamide) Niacinamide10 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride10 mg
Folic Acid (Folic Acid) Folic Acid1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin15 ug
Calcium Malate (Calcium Cation) Calcium Cation100 mg
Iron Pentacarbonyl (Ferrous Cation) Ferrous Cation30 mg
Ferrous Asparto Glycinate (Ferrous Cation) Ferrous Cation20 mg
Magnesium Malate (Magnesium Cation) Magnesium Cation15 mg
Zinc Glycinate (Zinc Cation) Zinc Cation10 mg
Cupric Glycinate (Cupric Cation) Cupric Cation1 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline 
Calcium Phosphate 
Croscarmellose Sodium 
Hypromelloses 
Titanium Dioxide 
Silicon Dioxide 
Stearic Acid 
Magnesium Stearate 
Acacia 
Polyethylene Glycols 
Povidones 
Ethylcelluloses 
Talc 
Polysorbate 80 
Castor Oil 
FD&C Red No. 40 
Aluminum Oxide 
Product Characteristics
ColorPINKScoreno score
ShapeOVAL (Oblong shaped) Size20mm
FlavorImprint Code VP043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:68025-043-303 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/31/2010
Labeler - Vertical Pharmaceuticals Inc. (173169017)

Revised: 6/2013
Document Id: 6e38db36-99e3-4886-8b4b-85b0790f4c13
Set id: ccdc12f4-24f6-453f-a855-9ce4e91641f1
Version: 2
Effective Time: 20130611
 
Vertical Pharmaceuticals Inc.