PreferaOB® Prenatal/Postnatal Multivitamin/ Multimineral Tablets

PreferaOB by

Drug Labeling and Warnings

PreferaOB by is a Prescription medication manufactured, distributed, or labeled by Alaven Pharmaceutical LLC, Nexgen Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREFERAOB- 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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PreferaOB®
Prenatal/Postnatal Multivitamin/
Multimineral Tablets

Rx Only

DESCRIPTION

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).

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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 tablet daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

HOW SUPPLIED

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.

STORAGE

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

www.PreferaOB.com

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

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

NDC: 68220-084-90
90 Tablets

PreferaOB®

www.PreferaOB.com

Manufactured for:
ALAVEN®
PHARMACEUTICAL LLC
Marietta, GA 30062

Rx Only

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
PREFERAOB 
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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68220-084
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
HEME IRON POLYPEPTIDE (UNII: 31VDO12CJY) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION6 mg
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION28 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION250 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.5 ug
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM65 ug
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION0.8 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D-10 [iU]
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE17 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE50 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 66 mg
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 51.5 mg
MAGNESIUM STEARATE (UNII: 70097M6I30) 5 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5 mg
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) 26 mg
DEXTRAN 1 (UNII: I8LHQ0D645)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SUCROSE (UNII: C151H8M554)  
BRINOLASE (UNII: Z3GVO2327F)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM ASCORBATE (UNII: S033EH8359)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorPURPLEScore2 pieces
ShapeOVALSize15mm
FlavorImprint Code AP;84
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68220-084-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/27/201001/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/27/201001/01/2019
Labeler - Alaven Pharmaceutical LLC (140210829)

Revised: 9/2010
 
Alaven Pharmaceutical LLC