Paire OB Plus DHA

Name: Paire OB Plus DHA

What do I need to tell my doctor BEFORE I take Paire OB Plus DHA?

All products:

  • If you have an allergy to this medicine or any part of Paire OB Plus DHA.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have too much iron in your body.

Products with vitamin A:

  • If you are taking acitretin.

Products with omega-3 fatty acids:

  • If you are taking a blood thinner.
  • If you have bleeding problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Paire OB Plus DHA with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of Paire OB Plus DHA?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Upset stomach or throwing up.
  • Change in color of stool to green.
  • Loose stools (diarrhea).
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

Contraindications

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

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.

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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Stomach cramps.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Upset stomach or throwing up.
  • Change in color of stool to green.
  • Loose stools (diarrhea).
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Paire OB Plus DHA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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