OB COMPLETE™ with DHA Prenatal Multivitamin/Multimineral

OB COMPLETE™ with DHA Prenatal Multivitamin/Multimineral

Drug Labeling and Warnings

Drug Details

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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

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OB COMPLETE™ with DHA
Prenatal Multivitamin/Multimineral

SUPPLEMENT FACTS

OB CompleteDHASF

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

Customer Service: 1-866-600-4799                                                                  Rev. 10/2018

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

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PRINCIPAL DISPLAY PANEL - 60 Softgel Bottle Label

OB
Complete®

with DHA
Prenatal
Multivitamin

68025-049-60
60 Softgels

OBCompleteDHABLREV102018
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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-049
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids200 mg
Calcium Ascorbate (UNII: 183E4W213W) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid120 mg
Calcium Threonate (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Threonate5 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol1000 [iU]
.Alpha.-Tocopherol, D- (UNII: N9PR3490H9) (.Alpha.-Tocopherol, D- - UNII:N9PR3490H9) .Alpha.-Tocopherol, D-30 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine2 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin3.4 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride30 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin15 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
Ferrous Asparto Glycinate (UNII: H7426RGB3L) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation10 mg
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Cation1 mg
Inactive Ingredients
Ingredient NameStrength
Soybean Oil (UNII: 241ATL177A)  
Gelatin (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Water (UNII: 059QF0KO0R)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Pigment Red 48 (UNII: 07XHK4SAV6)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ethyl Vanillin (UNII: YC9ST449YJ)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:68025-049-6060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/01/2011
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)15 mm
Labeler - Vertical Pharmaceuticals, LLC (173169017)

Revised: 10/2018
 
Vertical Pharmaceuticals, LLC


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