OB Complete 400: Package Insert and Label Information

OB COMPLETE 400- fish oil, doconexent, omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, calcium ascorbate, calcium threonate, .alpha.-tocopherol, d-, niacin, cupric sulfate anhydrous, zinc oxide, iron pentacarbonyl and ferrous asparto glycinate capsule, liquid filled
Vertical Pharmaceuticals Inc.

SUPPLEMENT FACTS
Serving Size: 1 Softgel Capsule
Servings Per Box: 30
For Pregnant and
Lactating Women
Amount per Serving % Daily Value
*
Eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA) ratio is approximately 1:16 and are derived from purified fish oils.
Daily Value has not been established
Purified Fish Oil * 400 mg
Docosahexaenoic Acid (DHA) 320 mg
Other Omegas (as EPA, ALA and Linoleic Acid) 40 mg
Vitamin B1 (Thiamine Mononitrate) 2 mg 118%
Vitamin B2 (Riboflavin) 3.4 mg 170%
Vitamin B6 (Pyridoxine HCl) 40 mg 1600%
Vitamin B12 (Cyanocobalamin) 20 mcg 250%
Folic Acid 1 mg 125%
Vitamin D3 (Cholecalciferol) 1000 IU 250%
Vitamin C (Calcium ascorbate and calcium threonate) 110 mg 183%
Vitamin E 30 IU 100%
Vitamin B3 (Niacin) 10 mg 50%
Copper (Sulfate) 1 mg 50%
Zinc (Zinc Oxide) 25 mg 167%
Ferronyl Iron 40 mg 222%
Sumalate® (Elemental Iron)‡ 10 mg 56%

Other Ingredients: Gelatin, Purified Water, Yellow Bees Wax, Vanillin, Glycerin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1

INDICATIONS AND USAGE

OB Complete™ 400 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 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™ 400 softgels 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™ 400 are pink color soft gelatin capsules, imprinted “VP048″.

HOW SUPPLIED

OB Complete™ 400 is available in carton unit dose pack of 30 (3 child resistant blister cards of 10 softgels per card). Product Code 68025-048-30.

STORAGE

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

‡ 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; 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)

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. 03/2013

PRINCIPAL DISPLAY PANEL — 30 Softgel Carton

OB
complete™
400

Prenatal
Multivitamin
with DHA

30
SOFTGELS

Rx Only

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

68025-048-30

VERTICAL
PHARMACEUTICALS, INC.

US Patent No. 6,716,814
5,516,925
8,007,846

Principal Display Panel -- 30 Softgel Carton
(click image for full-size original)
OB COMPLETE 400
fish oil, doconexent, omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, calcium ascorbate, calcium threonate, .alpha.-tocopherol, d-, niacin, cupric sulfate anhydrous, zinc oxide, iron pentacarbonyl, and ferrous asparto glycinate capsule, liquid filled
Product Information
Product Type Item Code (Source) NDC:68025-048
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fish Oil (Fish Oil) Fish Oil 400 mg
Doconexent (Doconexent) Doconexent 320 mg
Omega-3 Fatty Acids (Omega-3 Fatty Acids) Omega-3 Fatty Acids 40 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 2 mg
Riboflavin (Riboflavin) Riboflavin 3.4 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 40 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 20 ug
Folic Acid (Folic Acid) Folic Acid 1 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 1000 [iU]
Calcium Ascorbate (Ascorbic Acid) Ascorbic Acid 100 mg
Calcium Threonate (Calcium cation) Ascorbic Acid 10 mg
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
Niacin (Niacin) Niacin 10 mg
Cupric Sulfate Anhydrous (Cupric Cation) Cupric Cation 1 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 40 mg
Ferrous Asparto Glycinate (Ferrous Cation) Ferrous Cation 10 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin
Water
Yellow Wax
Ethyl Vanillin
Glycerin
Titanium Dioxide
FD&C Red No. 40
FD&C Blue No. 1
Product Characteristics
Color PINK Score no score
Shape OVAL Size 22mm
Flavor Imprint Code VP048
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-048-30 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (68025-048-30)
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.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.