Boxed 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.
PreferaOB One
- Manufacturer
- Alaven Pharmaceutical LLC | International Vitamin Corporation | Carton Services Inc
- Effective date
- 2010-03-08
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:52:52
Label at a glance#
ProductPreferaOB One
Active ingredientFOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Ascorbic Acid, CHOLECALCIFEROL, DOCONEXENT, .ALPHA.-TOCOPHEROL ACETATE, DL-, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE
Label structure12 sections
Indications and uses
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.
Dosage and administration
One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.
Contacts and useful links#
Websitewww.preferaob.com
www.PreferaOB.com
www.PreferaOB.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Prenatal/Postnatal Multivitamin/
Multimineral/DHA softgel
Rx Only
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:
| Vitamin C (as ascorbic acid) | 25 mg |
| Vitamin D3 (as cholecalciferol) | 400 IU |
| Vitamin E (as dl-alpha tocopheryl acetate) | 10 IU |
| Vitamin B3 (niacin as niacinamide) | 17 mg |
| Vitamin B6 (as pyridoxine HCl) | 50 mg |
| Folic Acid | 1 mg |
| Vitamin B12 (as cyanocobalamin) | 12 mcg |
| Biotin | 30 mcg |
| Vitamin B5 (as d-calcium pantothenate) | 10 mg |
| Iron | |
| as PIC (polysaccharide iron complex) | 22 mg |
| as HIP (heme iron polypeptide as | |
| Proferrin® * -bovine source, USDA certified) | 6 mg |
| Iodine (as potassium iodide) | 175 mcg |
| Zinc (as zinc oxide) | 15 mg |
| Docosahexaenoic Acid (DHA) | 200 mg |
* Proferrin® is a registered trademark of Colorado Biolabs, Inc , Cozad, NE.
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.
1 life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.
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.
STORAGE
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP]
To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.
For medical inquiries call toll free
1-888-317-0001
SPL UNCLASSIFIED SECTION
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!
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™
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68220-086-25 | 2020-02-04 | C162847 | 48780-1 | 956f9ecf-c609-621f-e053-dbdaa90a74ad | PreferaOB ONE ™ |
| 68220-086-30 | 2020-02-04 | C162847 | 48780-1 | 956f9ecf-c609-621f-e053-dbdaa90a74ad | PreferaOB ONE ™ |
| 68220-086-25 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c609-621f-e053-dbdaa90a74ad | PreferaOB ONE ™ |
| 68220-086-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c609-621f-e053-dbdaa90a74ad | PreferaOB ONE ™ |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68220-086-30 | EA - Each | 68220-086 | 9c17ad69-0af4-4801-a55e-5e215cfcdabe | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| Ascorbic Acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| BIOTIN | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| CALCIUM PANTOTHENATE | ACTIVE INGREDIENT | 568ET80C3D | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| DOCONEXENT | ACTIVE INGREDIENT | ZAD9OKH9JC | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Heme Iron Polypeptide | ACTIVE INGREDIENT | 31VDO12CJY | 1 | |
| IRON DEXTRAN | ACTIVE INGREDIENT | 95HR524N2M | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| Potassium Iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE MOIETY | WR1WPI7EW8 | 1 | |
| Ascorbic Acid | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| BIOTIN | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| CALCIUM PANTOTHENATE | ACTIVE MOIETY | 568ET80C3D | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| DOCONEXENT | ACTIVE MOIETY | ZAD9OKH9JC | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Heme Iron Polypeptide | ACTIVE MOIETY | 31VDO12CJY | 1 | |
| IRON DEXTRAN | ACTIVE MOIETY | 95HR524N2M | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| Potassium Cation | ACTIVE MOIETY | 295O53K152 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| HYDROGENATED SOYBEAN OIL | INACTIVE INGREDIENT | A2M91M918C | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| WAX, YELLOW | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- 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
- FOLIC ACID
- Heme Iron Polypeptide
- IRON DEXTRAN
- Potassium Iodide
- Potassium Cation
- Zinc Oxide
- Ascorbic Acid
- CHOLECALCIFEROL
- DOCONEXENT
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- CYANOCOBALAMIN
- BIOTIN
- CALCIUM PANTOTHENATE
- HYDROGENATED SOYBEAN OIL
- WAX, YELLOW
- GELATIN
- LECITHIN, SOYBEAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68220-086 | 68220-086-05, 68220-086-30, 68220-086-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FOLIC ACID | 935E97BOY8 | ACTIB |
| Heme Iron Polypeptide | 31VDO12CJY | ACTIB |
| IRON DEXTRAN | 95HR524N2M | ACTIB |
| Potassium Iodide | 1C4QK22F9J | ACTIB |
| Zinc Oxide | SOI2LOH54Z | ACTIB |
| Ascorbic Acid | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| DOCONEXENT | ZAD9OKH9JC | ACTIB |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | ACTIB |
| NIACINAMIDE | 25X51I8RD4 | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIB |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| BIOTIN | 6SO6U10H04 | ACTIB |
| CALCIUM PANTOTHENATE | 568ET80C3D | ACTIB |
| HYDROGENATED SOYBEAN OIL | A2M91M918C | IACT |
| WAX, YELLOW | 2ZA36H0S2V | IACT |
| GELATIN | 2G86QN327L | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | PASTILLE / ORAL | 143 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | CAPSULE / ORAL | 95 mg | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, COATED / ORAL | 3 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET / ORAL | 13.5 mg | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| HYDROGENATED SOYBEAN OIL | HYDROGENATED SOYBEAN OIL | A2M91M918C | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAMUSCULAR | 16 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| GELATIN | GELATIN | 2G86QN327L | ELIXIR / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CAPSULE / ORAL | 20 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, COATED / ORAL | 42.12 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | CREAM / TOPICAL | 5 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / RESPIRATORY (INHALATION) | 100 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| WAX, YELLOW | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 69e082a6-77dd-46e0-b3eb-90bb6d167b82 | db9fede8-b6d5-40a9-84cb-f928553f8e6c | 2010-03-08 | Boxed warning, Warnings, Adverse reactions | 69e082a6-77dd-46e0-b3eb-90bb6d167b82 db9fede8-b6d5-40a9-84cb-f928553f8e6c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.