PreferaOB ONE™
PreferaOB One by
Drug Labeling and Warnings
PreferaOB One by is a Prescription medication manufactured, distributed, or labeled by Alaven Pharmaceutical LLC, International Vitamin Corporation, Carton Services Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PREFERAOB ONE- folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin and calcium pantothenate capsule capsule
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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PreferaOB ONE™
DESCRIPTION
PreferaOB ONE™ is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™1). PreferaOB ONE™ is an oblong shaped, opaque purple colored softgel, imprinted "AP 86" in white ink on one side and plain on the other.
Each PreferaOB ONE™ Softgel contains:
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Vitamin C (as ascorbic acid) |
25 mg |
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Vitamin D3 (as cholecalciferol) |
400 IU |
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Vitamin E (as dl-alpha tocopheryl acetate) |
10 IU |
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Vitamin B3 (niacin as niacinamide) |
17 mg |
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Vitamin B6 (as pyridoxine HCl) |
50 mg |
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Folic Acid |
1 mg |
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Vitamin B12 (as cyanocobalamin) |
12 mcg |
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Biotin |
30 mcg |
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Vitamin B5 (as d-calcium pantothenate) |
10 mg |
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Iron | |
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as PIC (polysaccharide iron complex) |
22 mg |
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as HIP (heme iron polypeptide as | |
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Proferrin®* -bovine source, USDA certified) |
6 mg |
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Iodine (as potassium iodide) |
175 mcg |
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Zinc (as zinc oxide) |
15 mg |
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Docosahexaenoic Acid (DHA) |
200 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.
Inactive Ingredients
Gelatin, soybean oil, yellow beeswax, and lecithin.
INDICATIONS AND USAGE
PreferaOB ONE™ is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™) 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 ONE™ 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 0.1 mg 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 softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.
HOW SUPPLIED
PreferaOB ONE™ is supplied in child-resistant blister packs of 30 softgels (NDC: 68220-086-30) and as a Professional Sample (NDC: 68220-086-25).
KEEP OUT OF REACH OF CHILDREN.
Manufactured for:
Alaven® Pharmaceutical LLC
Marietta, GA 30062
U.S. Patent No. 7,585,527
PreferaOB® is a registered trademark and PreferaOB ONE™ is a trademark of Alaven® Pharmaceutical LLC, Marietta, GA.
CL6-086-00-01-1209a
PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Package
Rx Only
NDC: 68220-086-30
30 Softgels
PreferaOB ONE™
The Prenatal YOU CAN COUNT ON!
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FIRST and ONLY prenatal with Natural,
Body-Ready HEME Iron + DHA In
an all-in-one softgel
12 Essential Vitamins
and Minerals including:
- High dose of vitamin B6
- 1mg of folic acid
Plus Plant-based life'sDHA™ Omega-3
Pre/Post-natal Nutritional
Supplement + DHA
life'sDHA™
www.PreferaOB.com
| PREFERAOB ONE
folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin and calcium pantothenate capsule capsule |
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| Labeler - Alaven Pharmaceutical LLC (140210829) |