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.
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 ® is a prescription multivitamin/multimineral 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 ® is also beneficial in improving the nutritional status of women prior to conception.
One tablet daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.
Rx Only
PreferaOB® is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement. PreferaOB® 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.
| Each PreferaOB® 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 (niacin 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 (a complex of iron, glucose, maltose, and dextrin; Iron Content ~ 46%) yielding | 28 mg |
| as HIP (heme iron polypeptide as Proferrin®*- bovine source, USDA certified) yielding | 6 mg |
| Iodine (as potassium iodide) | 250 mcg |
| Zinc (as zinc oxide) | 4.5 mg |
| Selenium (as sodium selenate) | 65 mcg |
| Copper (as cupric sulfate) | 0.8 mg |
INACTIVE INGREDIENTS: Microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate, silicon dioxide, dextran, dicalcium phosphate, sucrose, protease, modified food starch, dl-alpha tocopherol, sodium ascorbate, ethylcellulose, resin, coating (polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake).
PreferaOB® is a prescription multivitamin/multimineral 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® is also beneficial in improving the nutritional status of women prior to conception.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
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.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One tablet daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.
PreferaOB® is supplied in a child-resistant bottle of 90 tablets (NDC 68220-084-90) and as a Professional Sample (NDC 68220-084-25).
KEEP OUT OF REACH OF CHILDREN.
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP]
Dispense in a tight, light-resistant container to protect from light and moisture.
For medical inquiries call toll free 1-888-317-0001
Manufactured for:
ALAVEN
®
PHARMACEUTICAL LLC
Marietta, GA.
U.S. Patent No. 7,585,527
*Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
PreferaOB® is a registered trademark of Alaven Pharmaceutical LLC,
Marietta, GA 30062
6-084-90-03-0710CR
CL6-084-00-01-0710a
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68220-084-90 | 2020-02-04 | C162847 | 48780-1 | 9d75b9cf-ffbc-f424-e053-dadaa90a57ce | PreferaOB ® Prenatal/Postnatal Multivitamin/ Multimineral Tablets |
| 68220-084-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ffbc-f424-e053-dadaa90a57ce | PreferaOB ® Prenatal/Postnatal Multivitamin/ Multimineral Tablets |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68220-084-90 | EA - Each | 68220-084 | a8b4fd78-64e0-41d7-918f-dc96d888404e | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ALPHA-TOCOPHEROL SUCCINATE, D- | ACTIVE INGREDIENT | LU4B53JYVE | 1 | |
| BIOTIN | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| CALCIUM PANTOTHENATE | ACTIVE INGREDIENT | 568ET80C3D | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CUPRIC SULFATE | ACTIVE INGREDIENT | LRX7AJ16DT | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 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 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| Selenium | ACTIVE INGREDIENT | H6241UJ22B | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| ALPHA-TOCOPHEROL SUCCINATE, D- | ACTIVE MOIETY | LU4B53JYVE | 1 | |
| BIOTIN | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| CALCIUM PANTOTHENATE | ACTIVE MOIETY | 568ET80C3D | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 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 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| Selenium | ACTIVE MOIETY | H6241UJ22B | 1 | |
| THIAMINE | ACTIVE MOIETY | X66NSO3N35 | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE | INACTIVE INGREDIENT | Z3GVO2327F | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 1 | |
| DEXTRAN 1 | INACTIVE INGREDIENT | I8LHQ0D645 | 1 | |
| ETHYLCELLULOSE | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) | INACTIVE INGREDIENT | 461P5CJN6T | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM ASCORBATE | INACTIVE INGREDIENT | S033EH8359 | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68220-084 | 68220-084-90 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | PASTILLE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| ETHYLCELLULOSE | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER / ORAL | 2090 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | SOAP / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | CAPSULE / ORAL | 6 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FILM COATED / ORAL | 1075 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, FILM COATED / ORAL | 0.26 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, CHEWABLE / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, CHEWABLE / ORAL | 50 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | INJECTION / INTRAVENOUS | 625 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | PASTE, DENTIFRICE / DENTAL | 48.36 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, CHEWABLE / ORAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg |
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 |
|---|---|---|---|---|---|---|
| aa72cc66-8257-4185-b563-894032636337 | b581311a-4ff9-4574-ba62-218288a59543 | 2010-09-13 | Boxed warning, Adverse reactions | aa72cc66-8257-4185-b563-894032636337 b581311a-4ff9-4574-ba62-218288a59543 |
Adverse event summaries are temporarily unavailable. Other product information remains available.