OB COMPLETE PRENATAL- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, pantothenic acid, iron pentacarbonyl, magnesium oxide, zinc oxide, and copper gluconate tablet

OB Complete Prenatal by

Drug Labeling and Warnings

OB Complete Prenatal 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, Di Cal 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, Povidone K30, Acacia

GLUTEN-, LACTOSE- AND SUGAR-FREE

OB Complete® 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.

Other Ingredients: Microcrystalline Cellulose, Di Cal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Povidone K30, Acacia.

GLUTEN, SUGAR AND LACTOSE FREE

CONTRAINDICATIONS

OB Complete® 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 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 an 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® caplets 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® is pink, capsule shaped caplet imprinted with "VP010".

DIRECTIONS FOR USE

Take one caplet by mouth daily or as directed by a physician.

HOW SUPPLIED

OB Complete® is supplied in a unit dose pack of 100 (10x10) caplets.

Product Code: 68025-010-10

STORAGE

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

WARNINGS

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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                         Rev. 08/2018

Distributed by:

Vertical Pharmaceuticals, LLC

Bridgewater, NJ 08807

www.verticalpharma.com

PRINCIPAL DISPLAY PANEL - 100 Caplet Blister Pack Carton

OB Complete® Prenatal Multivitamin

NDC: 68025-010-10
100 CAPLETS

INGREDIENTS AND APPEARANCE

OB COMPLETE PRENATAL 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, pantothenic acid, iron pentacarbonyl, magnesium oxide, zinc oxide, and copper gluconate tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:68025-010
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]
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R)	ascorbic acid	120 mg
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41)	cholecalciferol	315 [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	1.25 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	15 ug
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737)	Pantothenic Acid	5 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	50 mg
Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Cation	15 mg
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Cation	10 mg
COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg

Inactive Ingredients
Ingredient Name	Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
Croscarmellose Sodium (UNII: M28OL1HH48)
hypromelloses (UNII: 3NXW29V3WO)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
titanium dioxide (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Talc (UNII: 7SEV7J4R1U)
FD&C Red No. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
Magnesium Stearate (UNII: 70097M6I30)
povidone K30 (UNII: U725QWY32X)
acacia (UNII: 5C5403N26O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:68025-010-10	10 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)