OB Complete DHA: Package Insert and Label Information

OB COMPLETE DHA- omega-3 fatty acids, calcium ascorbate, calcium threonate, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, ferrous asparto glycinate, zinc oxide and cupric sulfate capsule, liquid filled
Vertical Pharmaceuticals Inc.

SUPPLEMENT FACTS
Serving Size: 1 Softgel CapsuleServings Per Container: 60 For Pregnant and Lactating Women
Amount per Serving % Daily Value
*
Eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA) ratio is approximately 1:1.5 and are derived from purified fish oils.
Daily Value has not been established
Acid metabolites, such as L-threonic, help with absorption of Vitamin C.
§
Sumalate® is a registered trademark of Albion International, Inc., Clearfield, UtahU.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)
Fatty Acids
Omega-3 Fatty Acids (DHA and EPA)* 200 mg
Vitamins
Vitamin C (Calcium Ascorbate and Calcium Threonate) 125 mg 208%
Vitamin D3 (Cholecalciferol) 1000 IU 250%
Vitamin E (d-Alpha Tocopherol) 30 IU 100%
Vitamin B1 (Thiamine Mononitrate) 2 mg 118%
Vitamin B2 (Riboflavin) 3.4 mg 170%
Vitamin B6 (Pyridoxine HCl) 30 mg 1200%
Folic Acid (Vitamin B9) 1 mg 125%
Vitamin B12 (Cyanocobalamin) 15 mcg 188%
Minerals
Iron (Ferronyl) 30 mg 167%
Sumalate® (Ferrous Asparto Glycinate)§ 10 mg 56%
Zinc (Zinc Oxide) 25 mg 167%
Copper (Sulfate) 1 mg 50%

Other Ingredients

Soybean Oil, Gelatin, Glycerin, Yellow Bees Wax, Purified Water, Lecithin, Carmine Hydrosoluble, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1

THIS PRODUCT CONTAINS SOYBEAN OIL AND FISH OIL.

INDICATIONS AND USAGE

OB Complete™ with DHA 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

OB Complete™ with DHA should not be used by patients with a known hypersensitivity to any of the listed ingredients including fish and fish oil.

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids [including alphalinolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. 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 yrs. 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™ with DHA softgel 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 softgel daily or as prescribed by a physician.

DESCRIPTION

OB Complete™ with DHA is purple colored softgel capsule, imprinted “VP049″.

HOW SUPPLIED

OB Complete™ with DHA is available in a 60 count bottle, Product Code 68025-049-60.

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F) [See USP] Protect from light, moisture and excessive heat.

PATENTED FORMULA: U.S. PAT. No. 8,263,137

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. 01/2013

PRINCIPAL DISPLAY PANEL — 60 Softgel Bottle Label

OB
complete™
with DHA
Prenatal
Multivitamin

Provides “Complete”
Nutrition for You
and Your Baby
Before, During
and After
Pregnancy

68025-049-60
60 Softgels

Rx ONLY
PATENTED FORMULA
U.S. PAT. No. 8,263,137

See accompanying product literature
for complete prescribing information.

Sumalate® Patents: U.S. Pat. No. 6,716,814;U.S. Pat. No. 5,516,925; U.S. Pat. No. 8,007,846

PRINCIPAL DISPLAY PANEL -- 60 Softgel Bottle Label
(click image for full-size original)
OB COMPLETE DHA omega-3 fatty acids, calcium ascorbate, calcium threonate, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, ferrous asparto glycinate, zinc oxide, and cupric sulfate capsule, liquid filled
Product Information
Product Type Item Code (Source) NDC:68025-049
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Omega-3 Fatty Acids (Omega-3 Fatty Acids) Omega-3 Fatty Acids 200 mg
Calcium Ascorbate (Ascorbic Acid) Ascorbic Acid 120 mg
Calcium Threonate (Calcium cation) Ascorbic Acid 5 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 1000 [iU]
.Alpha.-Tocopherol, D- (.Alpha.-Tocopherol, D-) .Alpha.-Tocopherol, D- 30 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 2 mg
Riboflavin (Riboflavin) Riboflavin 3.4 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 30 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 15 ug
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 30 mg
Ferrous Asparto Glycinate (Ferrous Cation) Ferrous Cation 10 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Sulfate (Cupric Cation) Cupric Cation 1 mg
Inactive Ingredients
Ingredient Name Strength
Soybean Oil
Gelatin
Glycerin
Yellow Wax
Water
Lecithin, Soybean
Pigment Red 48
Titanium Dioxide
Ethyl Vanillin
FD&C Red No. 40
FD&C Blue No. 1
Product Characteristics
Color PURPLE Score no score
Shape CAPSULE (Size 12 Oval) Size 15mm
Flavor Imprint Code VP049
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-049-60 60 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 07/01/2011
Labeler — Vertical Pharmaceuticals Inc. (173169017)

Revised: 05/2013 Vertical Pharmaceuticals Inc.

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