OB Complete Petite: Package Insert and Label Information

OB COMPLETE PETITE- calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, ferrous asparto glycinate, zinc oxide, cupric sulfate and doconexent capsule, liquid filled
Vertical Pharmaceuticals, LLC

SUPPLEMENT FACTS

Supplement Facts box
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Other Ingredients: Soybean Oil, Yellow Bees Wax, Lecithin, Gelatin, Purified Water, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Blue #1.

CONTAINS: SOY AND FISH OIL (ANCHOVY)

GLUTEN-, LACTOSE-, AND SUGAR-FREE

OB Complete® Petite 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

This product is contraindicated in patients with a known hypersensitivity to any of the 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 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®Petite softgel capsules 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® Petite is an oval-shaped plum colored softgel capsule, imprinted “VP 059 “.

DIRECTIONS FOR USE

One softgel capsule daily or as directed by a physician.

HOW SUPPLIED

OB Complete® Petite is supplied in a 30 count child-resistant bottle.

Product Code: 68025-059-30

STORAGE

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

KEEP OUT OF REACH OF CHILDREN.

PATENTED FORMULA. U.S. PAT. No. 8,263,137

**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. 06/2018

Distributed by:

Vertical Pharmaceuticals, LLC

Bridgewater, NJ 08807

vERTICAL LOGO

PRINCIPAL DISPLAY PANEL — 30 Capsule Bottle Label

68025-059-30

OB COMPLETE ®

Petite

Gluten,
Lactose and
Sugar-Free

VERTICAL
PHARMACEUTICALS, LLC

30 SOFTGEL CAPSULES

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Label 2
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OB COMPLETE PETITE
calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, ferrous asparto glycinate, zinc oxide, cupric sulfate, and doconexent capsule, liquid filled
Product Information
Product Type Item Code (Source) NDC:68025-059
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 75 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
THIAMINE MONONITRATE (Thiamine ION) THIAMINE 2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 30 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
IRON (IRON) IRON 35 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 5 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 200 mg
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL
YELLOW WAX
LECITHIN, SOYBEAN
GELATIN
WATER
TITANIUM DIOXIDE
FD&C RED NO. 40
ETHYL VANILLIN
FD&C BLUE NO. 1
Product Characteristics
Color PURPLE (Plum colored) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code VP059
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-059-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/26/2012
Labeler — Vertical Pharmaceuticals, LLC (173169017)

Revised: 04/2018 Vertical Pharmaceuticals, LLC

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