OB Complete Prenatal: Package Insert and Label Information

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
Vertical Pharmaceuticals, LLC

SUPPLEMENT FACTS

Supplement Facts Table
(click image for full-size original)

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 (10×10) 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.

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

Vertical Logo

PRINCIPAL DISPLAY PANEL — 100 Caplet Blister Pack Carton

OB Complete ® Prenatal Multivitamin

NDC 68025-010-10 100 CAPLETS

OB Complete Prenatal Carton Rev. 082018
(click image for full-size original)

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 Item Code (Source) NDC:68025-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.beta.-carotene (.beta.-carotene) .beta.-carotene 2100 [iU]
ascorbic acid (ascorbic acid) ascorbic acid 120 mg
cholecalciferol (cholecalciferol) cholecalciferol 315 [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 1.25 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 15 ug
Pantothenic Acid (Pantothenic Acid) Pantothenic Acid 5 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 50 mg
Magnesium Oxide (Magnesium Cation) Magnesium Cation 15 mg
Zinc Oxide (Zinc Cation) Zinc Cation 10 mg
COPPER GLUCONATE (CUPRIC CATION) CUPRIC CATION 1 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
Croscarmellose Sodium
hypromelloses
POLYVINYL ALCOHOL, UNSPECIFIED
titanium dioxide
POLYETHYLENE GLYCOL, UNSPECIFIED
Talc
FD&C Red No. 40
SILICON DIOXIDE
stearic acid
Magnesium Stearate
povidone K30
acacia
Product Characteristics
Color PINK Score no score
Shape OVAL (oblong) Size 19mm
Flavor Imprint Code VP010
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-010-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68025-010-10)
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: 12/2019 Vertical Pharmaceuticals, LLC

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