OB Complete Chewable: Package Insert and Label Information

OB COMPLETE CHEWABLE- ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron pentacarbonyl, ferrous asparto glycinate, magnesium glycinate, zinc glycinate and ulkenia dha oil tablet, chewable
Vertical Pharmaceuticals Inc.

PRESCRIBING INFORMATION

Supplement Facts
Serving Size: 1 Chewable TabletServings per Box:30 For Pregnant and Lactating Women
Amount per Serving % Daily Value
*
DimaCal and TRAACS are registered trademarks of Albion Laboratories, Inc. Malates covered by U.S. Patent 6,706,904, Chelate covered by U.S. Patent 7,838,042; and patents pending.
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. Appl. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028
DHA Sourced from Algae
§
Daily Value not established
Vitamin C (Ascorbic Acid and Sodium Ascorbate) 120 mg 200%
Vitamin D3 (Cholecalciferol) 800 IU 200%
Vitamin E (d-Alpha Tocopheryl Acetate) 30 IU 100%
Vitamin B1 (Thiamine Mononitrate) 2 mg 118%
Vitamin B2 (Riboflavin) 3 mg 150%
Vitamin B3 (Niacinamide) 10 mg 50%
Vitamin B6 (Pyridoxine HCl) 10 mg 400%
Folic Acid 1 mg 125%
Vitamin B12 (Cyanocobalamin) 15 mcg 188%
Calcium (as DimaCal® di-Calcium Malate)* 20 mg 2%
Ferronyl Carbonyl Iron (Elemental Iron) 15 mg 83%
Sumalate® (Ferrous Asparto Glycinate) 5 mg 28%
Magnesium (as di-Magnesium Malate)* 1.2 mg 2%
Zinc (as TRAACS® Zinc Glycinate Chelate)* 2 mg 13%
DHA (Docosahexaenoic Acid) 100 mg §

Other Ingredients

Microcrystalline Cellulose, Sorbitol, Sucrose, Natural Wild Berry Flavor, Sucralose, Natural Citrus Punch Flavor, Stearic Acid, Magnesium Stearate, Citric Acid, Fumed Silica, and FD&C Blue No. 2 Lake

THIS PRODUCT CONTAINS SOYBEAN OIL

DESCRIPTION

OB Complete™ Chewable is light blue speckled tablet, imprinted “VP039″ on one side and bisected on the other.

INDICATIONS

OB Complete™ Chewable 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.

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.

DRUG INTERACTIONS

OB Complete™ Chewable tablets are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.

DOSAGE AND ADMINISTRATION

One chewable tablet daily or as prescribed by a physician.

HOW SUPPLIED

OB Complete™ Chewable is available in carton unit dose pack of 30 (5 child resistant blister cards of 6 tablets per card.) 68025-039-30

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).

Manufactured for: Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872
www.verticalpharma.com
Rev. 05/12

PRINCIPAL DISPLAY PANEL — 30 Tablet Carton

68025-039-30
Rx Only

Part of the
Complete
Family of Next
Generation
Prenatal
Nutrition.
For You and
Your Baby
Before, During,
and After
Pregnancy

NEW
OB
COMPLETE™

Chewable

One Chewable Tablet Daily

  • Only Chewable Tablet with DHA
  • 800 IU Vitamin D3
  • 1 mg Folate

VERTICALPHARMACEUTICALS, INC.

Principal Display Panel -- 30 Tablet Carton
(click image for full-size original)
OB COMPLETE CHEWABLE ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron pentacarbonyl, ferrous asparto glycinate, magnesium glycinate, zinc glycinate, and ulkenia dha oil tablet, chewable
Product Information
Product Type Item Code (Source) NDC:68025-039
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 50 mg
Sodium Ascorbate (Ascorbic Acid) Sodium Ascorbate 70 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 800 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 2 mg
Riboflavin (Riboflavin) Riboflavin 3 mg
Niacinamide (Niacinamide) Niacinamide 10 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 10 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 15 ug
CALCIUM MALATE (CALCIUM MALATE) CALCIUM MALATE 20 mg
IRON PENTACARBONYL (Ferrous Cation) Ferrous Cation 15 mg
FERROUS ASPARTO GLYCINATE (Ferrous Cation) Ferrous Cation 5 mg
MAGNESIUM GLYCINATE (MAGNESIUM CATION) MAGNESIUM GLYCINATE 1.2 mg
ZINC GLYCINATE (Zinc Cation) Zinc Cation 2 mg
ULKENIA DHA OIL (ULKENIA DHA OIL) ULKENIA DHA OIL 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
Sorbitol
Sucrose
Sucralose
Stearic Acid
Magnesium Stearate
Citric Acid Monohydrate
Silicon Dioxide
FD&C Blue No. 2
Aluminum Oxide
Product Characteristics
Color BLUE (Light Blue Speckled) Score 2 pieces
Shape ROUND Size 21mm
Flavor BERRY (Natural Wild Berry) , CITRUS (Natural Citrus Punch) Imprint Code VP039
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-039-30 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (68025-039-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/26/2012
Labeler — Vertical Pharmaceuticals Inc. (173169017)

Revised: 07/2013 Vertical Pharmaceuticals Inc.

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