PreferaOB One

Alaven Pharmaceutical LLC

PreferaOB ONE

FULL PRESCRIBING INFORMATION: CONTENTS*

• PREFERAOB ONE DESCRIPTION
• PREFERAOB ONE INDICATIONS AND USAGE
• PREFERAOB ONE CONTRAINDICATIONS
• WARNING
• PRECAUTIONS
• PREFERAOB ONE ADVERSE REACTIONS
• PREFERAOB ONE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Package

FULL PRESCRIBING INFORMATION

Prenatal/Postnatal Multivitamin/
Multimineral/DHA softgel

Rx Only

PREFERAOB ONE DESCRIPTION

PreferaOB ONE^™ is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA^™ life'sDHA^™ is a trademark of Martek Biosciences Corporation, Columbia, MD.). PreferaOB ONE^™ is an oblong shaped, opaque purple colored softgel, imprinted "AP 86" in white ink on one side and plain on the other.

Each PreferaOB ONE^™ Softgel contains:

DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination.

Inactive Ingredients

Gelatin, soybean oil, yellow beeswax, and lecithin.

PREFERAOB ONE INDICATIONS AND USAGE

PreferaOB ONE^™ is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™) indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreferaOB ONE^™ is also beneficial in improving the nutritional status of women prior to conception.

PREFERAOB ONE CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Ingestion of more than 3 grams of Omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of Omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis.

PRECAUTIONS

Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

PREFERAOB ONE ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

PREFERAOB ONE DOSAGE AND ADMINISTRATION

One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

HOW SUPPLIED

PreferaOB ONE^™ is supplied in child-resistant blister packs of 30 softgels (NDC 68220-086-30) and as a Professional Sample (NDC 68220-086-25).

KEEP OUT OF REACH OF CHILDREN.

STORAGE

Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP]

To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.

For medical inquiries call toll free
1-888-317-0001

www.PreferaOB.com

Manufactured for:
Alaven^® Pharmaceutical LLC
Marietta, GA 30062

U.S. Patent No. 7,585,527

PreferaOB^® is a registered trademark and PreferaOB ONE^™ is a trademark of Alaven^® Pharmaceutical LLC, Marietta, GA.

CL6-086-00-01-1209a

PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Package

Rx Only
NDC 68220-086-30

30 Softgels

PreferaOB ONE^™

The Prenatal YOU CAN COUNT ON!

FIRST and ONLY prenatal with Natural,
Body-Ready HEME Iron + DHA In
an all-in-one softgel

12 Essential Vitamins
and Minerals including:

- High dose of vitamin B₆

- 1mg of folic acid

Plus Plant-based life'sDHA™ Omega-3

Pre/Post-natal Nutritional

Supplement + DHA

life'sDHA™

www.PreferaOB.com