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, LLC

SUPPLEMENT FACTS

OB CompleteDHASF
(click image for full-size original)

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

THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVIES, MACKEREL, SARDINES, TUNA).

GLUTEN-, LACTOSE- AND SUGAR-FREE

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 soy and fish oil.

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.

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 neurologic manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

DRUG INTERACTIONS

OB Complete® with DHA Prenatal Multivitamin/Multimineral is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

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.

DESCRIPTION

OB Complete® with DHA is a purple, oval shaped softgel capsule imprinted with “VP049”.

DIRECTIONS FOR USE

Take one softgel capsule by mouth daily or as directed by a physician.

HOW SUPPLIED

OB Complete® with DHA Prenatal Multivitamin/Multimineral softgels are available in 60 count bottles.

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.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

***Sumalate® (Ferrous Asparto Glycinate) is a registered trademark of Albion International, Inc. and is covered by the following patents: U.S. Pat. No. 6,716,814; U.S. Pat. No. 8,007,846 and U.S. Pat. No. 8,425,956.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Customer Service: 1-866-600-4799 Rev. 01/2020

Distributed by:
Vertical Pharmaceuticals, LLC
Bridgewater, NJ 08807
www.verticalpharma.com

verticallogo

PRINCIPAL DISPLAY PANEL — 60 Softgel Bottle Label

OB
Complete®

with DHA
Prenatal
Multivitamin

68025-049-60 60 Softgels

OB Complete with DHA Bottle Label Rev. 012020
(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) Calcium Threonate 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, LLC (173169017)

Revised: 02/2020 Vertical Pharmaceuticals, LLC

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.