OB Complete One: Package Insert and Label Information

OB COMPLETE ONE- fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide and cupric sulfate capsule, liquid filled
Vertical Pharmaceuticals, LLC

SUPPLEMENT FACTS

SF
(click image for full-size original)

Other Ingredients: Gelatin, Glycerin, Yellow Bees Wax, Purified Water, Lecithin (Soybean Oil), Natural Cream Orange Flavor, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1.

CONTAINS: SOY AND FISH (ANCHOVIES, MACKEREL, SARDINES, TUNA)

GLUTEN-, LACTOSE- AND SUGAR-FREE

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

WARNINGS

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.


Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.


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

DRUG INTERACTIONS

OB Complete® One softgels are 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® One is an oblong-shaped purple softgel, imprinted “VP044″.

DIRECTIONS FOR USE

One softgel by mouth daily or as directed by a physician.

HOW SUPPLIED

OB Complete® One is supplied in a carton of 30 capsules, packaged in 3 child resistant unit-dose blister cards of 10 softgels per card.

Product Code: 68025-044-30

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.

*DimaCal is a registered trademark of Albion International, Inc.

Malates covered by U.S. Patent No. 6,706,904.

**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

VERTICAL LOGO

PRINCIPAL DISPLAY PANEL

68025-044-30

OB COMPLETE ®
One

Gluten,
Lactose and
Sugar-Free

VERTICAL PHARMACEUTICALS, LLC

30 Softgels

TRADE CARTON REV. 01/2020
(click image for full-size original)
OB COMPLETE ONE
fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide, and cupric sulfate capsule, liquid filled
Product Information
Product Type Item Code (Source) NDC:68025-044
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FISH OIL (FISH OIL) FISH OIL 476 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 70 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1200 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
THIAMINE MONONITRATE (Thiamine ION) THIAMINE 2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 10 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 30 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 50 ug
BIOTIN (BIOTIN) BIOTIN 200 ug
CALCIUM THREONATE (CALCIUM CATION) CALCIUM THREONATE 5 mg
CALCIUM MALATE (CALCIUM CATION) CALCIUM CATION 25 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 25 mg
IRON (IRON) IRON 40 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 10 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 15 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
SOYBEAN OIL
LECITHIN, SOYBEAN
GELATIN
GLYCERIN
WATER
ORANGE OIL
TITANIUM DIOXIDE
FD&C RED NO. 40
ETHYL VANILLIN
FD&C BLUE NO. 1
Product Characteristics
Color PURPLE Score no score
Shape CAPSULE (Oblong) Size 23mm
Flavor ORANGE (Natural Creamy Orange) Imprint Code VP044
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-044-30 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 (68025-044-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 12/31/2010
Labeler — Vertical Pharmaceuticals, LLC (173169017)

Revised: 02/2020 Vertical Pharmaceuticals, LLC

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