Preferaob tablet, coated

Spl unclassified section

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:

D 3(as cholecalciferol) .........................400 IU
E (as d-alpha tocopheryl acid succinate) 10 IU
B 1(as thiamine mononitrate) ................1.5 mg
B 2(as riboflavin)..................................1.6 mg
B 3(niacin as niacinamide)......................17 mg
B 6(as pyridoxine HCl) .........................50 mg
Folic Acid ..............................................1 mg
B 12(as cyanocobalamin) .....................12 mcg
Biotin ................................................. 30 mcg
B 5(as d-calcium pantothenate)...............10 mgIron...34 mg
(as PIC - polysaccharide iron complex)
(as HIP - heme iron polypeptide as Proferrin®*)
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

VITAMINS

MINERALS

Other ingredients:

Microcrystalline cellulose, croscarmellose sodium, crospovidone, silicon dioxide, magnesium stearate (vegetable source), modified food starch, dibasic calcium phosphate, resin, sucrose, ethylcellulose, sodium ascorbate, medium chain triglycerides, dl-alpha tocopherol, 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.

Warnings section

Boxed warning section

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.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8408 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 0037-0084-90).

KEEP OUT OF REACH OF CHILDREN.

Storage:

Store at controlled room temperature 20-25C (68-77F). Excursions permitted to 15-30C (59-86F).

Dispense in a tight, light-resistant container to protect from light and moisture.

Spl unclassified section

  1. Distributed by:
    MEDA
    Meda Pharmaceuticals Inc.
    Somerset, New Jersey 08873-4120

    © 2015 Meda Pharmaceuticals Inc.

    U.S. Patent Nos. 7,585,527 and 8,080,520.

    Proferrin ®is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
    IN-6884-04 Rev 7/2015

Ingredients and appearance - Product information

Preferaob tablet, coated- Cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, d-, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, sodium selenate, cupric sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0037-0084
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cholecalciferol ( UNII: 1C6V77QF41)( Cholecalciferol - UNII: 1C6V77QF41 ) 400 [iU]in 1
.alpha.-tocopherol succinate, d- ( UNII: LU4B53JYVE)( .alpha.-tocopherol, d- - UNII: N9PR3490H9 ) 10 [iU]in 1
Thiamine mononitrate ( UNII: 8K0I04919X)( Thiamine ion - UNII: 4ABT0J945J ) 1.5 mgin 1
Riboflavin ( UNII: TLM2976OFR)( Riboflavin - UNII: TLM2976OFR ) 1.6 mgin 1
Niacinamide ( UNII: 25X51I8RD4)( Niacinamide - UNII: 25X51I8RD4 ) 17 mgin 1
Pyridoxine hydrochloride ( UNII: 68Y4CF58BV)( Pyridoxine - UNII: KV2JZ1BI6Z ) 50 mgin 1
Folic acid ( UNII: 935E97BOY8)( Folic acid - UNII: 935E97BOY8 ) 1 mgin 1
Cyanocobalamin ( UNII: P6YC3EG204)( Cyanocobalamin - UNII: P6YC3EG204 ) 12 ugin 1
Biotin ( UNII: 6SO6U10H04)( Biotin - UNII: 6SO6U10H04 ) 30 ugin 1
Calcium pantothenate ( UNII: 568ET80C3D)( Calcium cation - UNII: 2M83C4R6ZB ) 10 mgin 1
Iron sucrose ( UNII: FZ7NYF5N8L)( Ferric cation - UNII: 91O4LML611 ) 28 mgin 1
Heme iron polypeptide ( UNII: 31VDO12CJY)( Ferrous cation - UNII: GW89581OWR ) 6 mgin 1
Potassium iodide ( UNII: 1C4QK22F9J)( Iodide ion - UNII: 09G4I6V86Q ) 250 ugin 1
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 4.5 mgin 1
Sodium selenate ( UNII: 5DQP25600A)( Selenate ion - UNII: 6X37R1DB70 ) 65 ugin 1
Cupric sulfate ( UNII: LRX7AJ16DT)( Cupric cation - UNII: 8CBV67279L ) 0.8 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone ( UNII: 68401960MK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Modified corn starch (1-octenyl succinic anhydride) ( UNII: 461P5CJN6T)
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Sucrose ( UNII: C151H8M554)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Sodium ascorbate ( UNII: S033EH8359)
Medium-chain triglycerides ( UNII: C9H2L21V7U)
.alpha.-tocopherol, dl- ( UNII: 7QWA1RIO01)
Polyvinyl alcohol ( UNII: 532B59J990)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c red no. 30 ( UNII: 2S42T2808B)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)

Product Characteristics

Color PURPLE Size 15 mm
Shape OVAL Score 2
Imprint Code AP;84

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
Unapproved drug other USA

Labeler - MEDA Pharmaceuticals( 051229602)

Principal display panel 90 tablets label

NDC 0037-0084-90
PreferaOB ®

  1. Distributed by:
    MEDA
    Meda Pharmaceuticals Inc.
    Somerset, New Jersey 08873-4120

US Patent Nos. 7,585,527 and 8,080,502

©2015 Meda Pharmaceuticals Inc.

Rx Only

90 Tablets