Paire OB Plus DHA

Centrix Pharmaceutical, Inc.
Midlothian Laboratories

PaireOB™ PLUS DHA Maternal Nutritional Supplement

FULL PRESCRIBING INFORMATION: CONTENTS*

• PAIRE OB PLUS DHA DESCRIPTION
• INACTIVE INGREDIENTS
  • Each DHA gelatin capsule contains
• PAIRE OB PLUS DHA INDICATIONS AND USAGE
• PAIRE OB PLUS DHA CONTRAINDICATIONS
• WARNING
• PRECAUTIONS
• PAIRE OB PLUS DHA ADVERSE REACTIONS
• PAIRE OB PLUS DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - Kit Carton

FULL PRESCRIBING INFORMATION

PAIRE OB PLUS DHA DESCRIPTION

Paire OB Plus DHA is a prescription prenatal/postnatal multivitamin/mineral tablet and a gel capsule of an essential fatty acid. The prenatal vitamin is a scored, white, oval multivitamin/mineral tablet debossed and bisected with "ML" on one side and plain on the other. The essential fatty acid DHA capsule is a softgel containing a clear semi-solid mixture.

INACTIVE INGREDIENTS

Microcrystalline cellulose, dicalcium phosphate, croscarmellose sodium, magnesium stearate, silicon dioxide, crospovidone, ethocel, sodium ascorbate, hypromellose, titanium dioxide, polydextrose, talc, maltodextrin, medium chain triglycerides.

Each DHA gelatin capsule contains

Docosahexaenoic Acid (DHA) 200 mg

Inactive ingredients in the DHA softgel include: gelatin, glycerin USP, water.

PAIRE OB PLUS DHA INDICATIONS AND USAGE

Paire OB Plus DHA is a prescription multivitamin/multimineral and Omega-3 fatty acid nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Paire OB Plus DHA is also beneficial in improving the nutritional status of women prior to conception.

PAIRE OB PLUS DHA 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 hematologic 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.

PAIRE OB PLUS DHA ADVERSE REACTIONS

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

PAIRE OB PLUS DHA DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Paire OB Plus DHA is supplied in six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 11528-095-03.

KEEP OUT OF REACH OF CHILDREN.

You may report side effects to FDA at 1-800-FDA-1088 or to Centrix Pharmaceutical at 1-866-991-9871.

STORAGE

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

[See current USP]

Contact with moisture can discolor or erode the tablet.

Rx Only

Manufactured for:

Centrix Pharmaceutical, Inc.
Birmingham, AL 35242

CENTRIX^®, the Centrix Pharmaceutical logo, and PaireOB™ are trademarks of Centrix Pharmaceutical, Inc. ©2010

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 11528-095-03
Rx Only

PaireOB™
PLUS DHA
Maternal Nutritional Supplement

An Rx Prenatal Vitamin and
Omega-3 Docosahexaenoic Acid (DHA)

Rx Prenatal Vitamin Tablet and
200 mg DHA Gel Capsule

CENTRIX ^®
PHARMACEUTICAL, INC.