Paire OB Plus DHA

maternal nutritional supplement

Dosage Form: tablet
PaireOB™

PLUS DHA

Maternal Nutritional Supplement

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.

Each prenatal tablet contains:

VITAMINS
D3 (as cholecalciferol)	400 IU
E (as d-alpha tocopheryl succinate)	10 IU
B1 (as thiamin mononitrate)	1.5 mg
B2 (as riboflavin)	1.6 mg
B3 (as niacinamide)	17 mg
B6 (as pyridoxine HCl)	50 mg
Folic Acid	1 mg
B12 (as cyanocobalamin)	12 mcg
Biotin	30 mcg
B5 (as d-calcium pantothenate)	10 mg
MINERALS
Iron
(as polysaccharide iron complex)	22 mg
(as ferrous aspartate and iron glycinate)	6 mg
Iodine (as potassium iodide)	175 mcg
Zinc (as zinc oxide)	15 mg
Selenium (as sodium selenate)	65 mcg
Copper (as cupric sulfate)	0.8 mg

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.

Indications and Usage for Paire OB Plus DHA

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.

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.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

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.

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 is Paire OB Plus DHA 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.

Paire OB Plus DHA  Paire OB Plus DHA  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 11528-095

Packaging # NDC Package Description Multilevel Packaging 1 11528-095-03 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 6 BLISTER PACK   30  Part 2 6 BLISTER PACK   30

Part 1 of 2 Paire OB Plus DHA  vitamin d, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, iron, ferrous asparto glycinate, potassium iodide, zinc oxide, sodium selenate, and cupric sulfate  tablet

Product Information       Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL ACETATE, D-) .ALPHA.-TOCOPHEROL ACETATE, D- 10 [iU] THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.5 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.6 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug BIOTIN (BIOTIN) BIOTIN 30 ug CALCIUM PANTOTHENATE (CALCIUM PANTOTHENATE) CALCIUM PANTOTHENATE 10 mg IRON (IRON) IRON 22 mg FERROUS ASPARTO GLYCINATE (FERROUS ASPARTO GLYCINATE) FERROUS ASPARTO GLYCINATE 6 mg POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 175 ug ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg SODIUM SELENATE (SODIUM CATION) SODIUM SELENATE 65 ug CUPRIC SULFATE (CUPRIC CATION) CUPRIC SULFATE 0.8 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE   HYDRATED SILICA   CROSPOVIDONE   ETHYLCELLULOSE (100 CPS)   SODIUM ASCORBATE   HYPROMELLOSES   TITANIUM DIOXIDE   POLYDEXTROSE   TALC   MALTODEXTRIN   MEDIUM-CHAIN TRIGLYCERIDES

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 15mm Flavor Imprint Code ML Contains

Packaging # NDC Package Description Multilevel Packaging 1 5 TABLET In 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/13/2010

Part 2 of 2 Paire OB Plus DHA  doconexent  capsule, gelatin coated

Product Information       Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (DOCONEXENT) DOCONEXENT 200 mg

Inactive Ingredients Ingredient Name Strength GELATIN   GLYCERIN   WATER

Product Characteristics Color BROWN Score no score Shape CAPSULE Size 13mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 5 CAPSULE In 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/13/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/13/2010

Labeler - Centrix Pharmaceutical, Inc. (185405367)

Registrant - Midlothian Laboratories (142122824)

Establishment
Name	Address	ID/FEI	Operations
Avema Pharma Solutions		804087794	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Tishcon Corporation		195342449	MANUFACTURE

Revised: 10/2010Centrix Pharmaceutical, Inc.

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