OB COMPLETE PREMIER- .beta.-carotene, calcium ascorbate, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron, ferrous asparto glycinate, magnesium malate, zinc glycinate, and copper tablet, coated

OB Complete Premier by

Drug Labeling and Warnings

OB Complete Premier 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: Microcrystalline Cellulose, DiCal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc and FDC Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Acacia and Povidone K30.

VEGETARIAN FRIENDLY

GLUTEN-, LACTOSE- AND SUGAR-FREE

OB Complete® Premier 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® Premier should not be used by patients with a known hypersensitivity to any of the listed ingredients.

WARNINGS

 WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP 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® Premier tablets 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® Premier is pink tablet, imprinted "VP043".

DIRECTIONS FOR USE

One tablet daily or as directed by a physician.

HOW SUPPLIED

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

Product Code: 68025-043-30

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 and TRAACS are registered trademarks of Albion International, Inc. Malates covered by U.S. Patent No. 6,706,904. Chelate covered by U.S. Patent No. 7,838,042 and patents pending.

**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 1-877-95-VERTI (1-877-958-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 
Customer Service: 1-866-600-4799

Distributed by:
Vertical Pharmaceuticals, LLC
Bridgewater, NJ 08807

Rev. 06/2018

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

68025-043-30

Vegetarian Friendly,
Gluten, Lactose and
Sugar-Free

OB
COMPLETE®
Premier

30 Tablets

VERTICAL
PHARMACEUTICALS, LLC

INGREDIENTS AND APPEARANCE

OB COMPLETE PREMIER 
.beta.-carotene, calcium ascorbate, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron, ferrous asparto glycinate, magnesium malate, zinc glycinate, and copper tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:68025-043
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	2100 [iU]
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	800 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	20 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	10 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	15 ug
CALCIUM MALATE (UNII: D48OP746DW) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	100 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	30 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	20 mg
MAGNESIUM MALATE (UNII: LA9X9UJA2Z) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	15 mg
ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 mg
CUPRIC GLYCINATE (UNII: 68VAV8QID7) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ACACIA (UNII: 5C5403N26O)
POVIDONE K30 (UNII: U725QWY32X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:68025-043-30	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
imprint
scoring	1
shape
size (solid drugs)	19 mm

Labeler - Vertical Pharmaceuticals, LLC (173169017)