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

OB Complete One by

Drug Labeling and Warnings

OB Complete One by is a Other medication manufactured, distributed, or labeled by Vertical Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

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.

HEALTH CLAIM

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

PRINCIPAL DISPLAY PANEL

68025-044-30

OB
COMPLETE®
One

Gluten,
Lactose and
Sugar-Free

VERTICAL
PHARMACEUTICALS, LLC

30 Softgels

INGREDIENTS AND APPEARANCE

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	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:68025-044
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F)	FISH OIL	476 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	300 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA)	ICOSAPENT	40 mg
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	70 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1200 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	10 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	30 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	50 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	200 ug
CALCIUM THREONATE (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM THREONATE	5 mg
CALCIUM MALATE (UNII: D48OP746DW) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	25 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	25 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	40 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	10 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SOYBEAN OIL (UNII: 241ATL177A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ORANGE OIL (UNII: AKN3KSD11B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ETHYL VANILLIN (UNII: YC9ST449YJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:68025-044-30	3 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		12/31/2010

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor
imprint
scoring	1
shape
size (solid drugs)	23 mm

Labeler - Vertical Pharmaceuticals, LLC (173169017)