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Paire OB Plus DHA

Generic Name: maternal nutritional supplement
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 LABEL Item Code (Source) NDC:11528-095
Packaging
# Item Code Package Description
1 NDC:11528-095-03 1 KIT (KIT) in 1 CARTON
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
# Item Code Package Description
1 5 TABLET (TABLET) in 1 BLISTER PACK
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
# Item Code Package Description
1 5 CAPSULE, GELATIN COATED (CAPSULE) in 1 BLISTER PACK
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: 10/2010
 
Centrix Pharmaceutical, Inc.
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