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.
