OB Complete Premier: Package Insert and Label Information

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

SUPPLEMENT FACTS

OBComplete Premier Supplement Facts box
(click image for full-size original)

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.

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

logo

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

Carton
(click image for full-size original)
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 Item Code (Source) NDC:68025-043
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2100 [iU]
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 20 [iU]
THIAMINE MONONITRATE (Thiamine ION) THIAMINE 2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 10 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
CALCIUM MALATE (CALCIUM CATION) CALCIUM CATION 100 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 30 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 20 mg
MAGNESIUM MALATE (MAGNESIUM CATION) MAGNESIUM CATION 15 mg
ZINC GLYCINATE (ZINC CATION) ZINC CATION 10 mg
CUPRIC GLYCINATE (CUPRIC CATION) CUPRIC CATION 1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
TALC
FD&C RED NO. 40
SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
ACACIA
POVIDONE K30
Product Characteristics
Color PINK Score no score
Shape OVAL (Oblong shaped) Size 19mm
Flavor Imprint Code VP043
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-043-30 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (68025-043-30)
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: 07/2018 Vertical Pharmaceuticals, LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.