Prenatal/Postnatal Multivitamin/ Multimineral PreferaOB® Tablets & life'sDHA™* Softgels
PreferaOB plus DHA by
Drug Labeling and Warnings
PreferaOB plus DHA by is a Prescription medication manufactured, distributed, or labeled by Alaven Pharmaceutical LLC, Nexgen Pharma Inc., Carton Services Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PREFERAOB PLUS DHA- folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, selenium, cupric sulfate, cholecalciferol, thiamine mononitrate, alpha-tocopherol succinate, d-, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, and calcium pantothenate tablet
Alaven Pharmaceutical LLC
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.
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Prenatal/Postnatal Multivitamin/
Multimineral PreferaOB® Tablets &
life'sDHA™* Softgels
DESCRIPTION
PreferaOB + DHA™ is a prescription prenatal/postnatal multivitamin/multimineral (PreferaOB®) and Omega-3 fatty acid (life'sDHA™) nutritional supplement. PreferaOB + DHA™ is: a small, oval, film-coated, purple tablet with black core, debossed and bisected with "AP/84" on one side, and plain on the other (PreferaOB®) and a clear essential fatty acid softgel containing an amber to light/dark orange semi-solid mixture (life'sDHA™).
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Each PreferaOB® tablet contains: |
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VITAMINS |
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D3 (as cholecalciferol) |
400 IU |
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E (as d-alpha tocopheryl succinate) |
10 IU |
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B1 (as thiamin mononitrate) |
1.5 mg |
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B2 (as riboflavin) |
1.6 mg |
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B3 (niacin as niacinamide) |
17 mg |
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B6 (as pyridoxine HCl) |
50 mg |
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Folic Acid |
1 mg |
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B12 (as cyanocobalamin) |
12 mcg |
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Biotin |
30 mcg |
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B5 (as d-calcium pantothenate) |
10 mg |
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MINERALS | |
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Iron | |
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as Polysaccharide Iron Complex (a complex of iron, glucose, maltose, and dextrin; Iron Content ~ 46%) yielding |
28 mg |
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as HIP (heme iron polypeptide as Proferrin®** - |
6 mg |
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Iodine (as potassium iodide) |
250 mcg |
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Zinc (as zinc oxide) |
4.5 mg |
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Selenium (as sodium selenate) |
65 mcg |
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Copper (as cupric sulfate) |
0.8 mg |
INACTIVE INGREDIENTS:
Microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate (vegetable source), silicon dioxide, dextran, dicalcium phosphate, protease, modified food starch, sucrose, dl-alpha tocopherol, sodium ascorbate, ethylcellulose, resin, coating (polydextrose, hypermellose, titanium dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake, polyethylene glycol, hydroxypropyl cellulose, purified water).
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Each life'sDHA™ Softgel contains: |
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Total omega-3 long chain fatty acids |
203 mg |
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as Docosahexaenoic Acid (DHA) |
200 mg |
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as α-linolenic acid (ALA) |
0.5 mg |
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as Docosapentaenoic acid (DPA) |
2.5 mg |
DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination. Ingredients include: DHA Algal Oil, High Oleic Sunflower Oil, Ascorbyl Palmitate & Tocopherols (as antioxidants) in a Gelatin Capsule (Gelatin, Glycerin, Water, and Caramel, Carmine, Calcium Carbonate and Turmeric as coloring).
INDICATIONS AND USAGE
PreferaOB + DHA™ is a prescription multivitamin/multimineral (PreferaOB®) and Omega-3 fatty acid (life'sDHA™) 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. PreferaOB + 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 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 0.1mg daily may obscure pernicious anemia in that hematological 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.
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
PreferaOB + DHA™ is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC: 68220-083-30) and as a Professional Sample (NDC: 68220-083-25).
KEEP OUT OF REACH OF CHILDREN.
For medical inquiries call toll free 1-888-317-0001
www.PreferaOB.com
life'sDHA™
HEALTHY BRAIN, EYES, HEART
Manufactured for:
ALAVEN®
PHARMACEUTICAL LLC
Alaven® Pharmaceutical LLC, Marietta, GA 30062
U.S. Patent No. 7,585,527
*life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.
**Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
PreferaOB® is a registered trademark and PreferaOB + DHA™ is a
trademark of Alaven® Pharmaceutical LLC, Marietta, GA.
6-083-30-06-0710CR
Ref CL6-083-00-01-0710b
PRINCIPAL DISPLAY PANEL - 30 Tablet Carton
Rx Only
NDC: 68220-083-30
30 Tablets + 30 Softgels
PreferaOB
+DHA™
life'sDHA™
HEALTHY BRAIN, EYES, HEART
ONLY prenatal with Natural,
Body-Ready HEME Iron + DHA
15 Essential Vitamins and
Minerals including:
- 50mg of vitamin B6
- 1mg of folic acid
Plus Plant-based life'sDHA™ Omega-3
Pre/Post-natal Nutritional
Supplement + DHA
www.PreferaOB.com
| PREFERAOB PLUS DHA
folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, selenium, cupric sulfate, cholecalciferol, thiamine mononitrate, alpha-tocopherol succinate, d-, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, and calcium pantothenate tablet |
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| Labeler - Alaven Pharmaceutical LLC (140210829) |