PRENA1- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, zinc oxide and doconexent capsule, gelatin coated 
BocaGreenMD Inc.

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Prena1
with Quatrefolic®

DESCRIPTION

Prena1 is a prescription prenatal/postnatal dietary supplement containing vitamins, minerals and vegetarian DHA within a purple, opaque softgel.

Supplement Facts

Serving Size: 1 Softgel

MULTIVITAMIN/MULTIMINERALAmount per Softgel% Daily Value Pregnant and Nursing Women
*
% Daily Value Not Established
Vitamin C (as ascorbic acid)60 mg100%
Vitamin D3 (as cholecalciferol)400 IU100%
Vitamin E (as dl-alpha tocopheryl acetate)21 IU70%
Vitamin B1 (as thiamine mononitrate)1.5 mg88%
Vitamin B2 (as riboflavin)1.7 mg85%
Vitamin B3 (as niacinamide)20 mg100%
Vitamin B6 (as pyridoxine HCl)25 mg1000%
Folate1 mg125%
  Quatrefolic® ((6S)-5-methyltetrahydrofolic
  acid, glucosamine salt)600 mcg
  Folic acid400 mcg
Vitamin B12 (as cyanocobalamin)8 mcg100%
Biotin (as d-Biotin)300 mcg100%
Pantothenic Acid (as d-calcium pantothenate)10 mg100%
Iron (as ferrous fumerate)30 mg167%
Zinc (as zinc oxide)7.5 mg50%
DHA (docosahexaenoic acid from algal oil)200 mg*

OTHER INGREDIENTS

Gelatin capsule (gelatin, purified water, vegetable glycerin), high oleic sunflower oil, beeswax, glycerol monostearate, soybean lecithin, purified water, titanium dioxide, sunflower lecithin, rosemary extract, tocopherols and ascorbyl palmitate, D&C Red #33, FD&C Red #40, FD&C Blue #1, orange essential oil.

INDICATIONS

Prena1 is a dietary supplement with DHA indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Prena1 can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

This product is contraindicated in patients with 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 the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

As a dietary supplement, take one softgel daily with a meal. For adults only. Consult your doctor before taking any supplement.

HOW SUPPLIED

Unit dose box of 30 softgels
Product Code 50265-199-30

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Marketed and Distributed by:

Boca
GREEN
MD
Boca Raton, Florida 33487
888.543.9160 www.BocaGreenMD.com

Quatrefolic® is a registered trademark of Gnosis Spa.
U.S. Patent No. 7,947,662; and other patents pending.

BOCA-0005 09/12

PRINCIPAL DISPLAY PANEL - 30 Softgel Carton

50265-199-30

Prena1
with Quatrefolic®

Prenatal Multivitamin
with DHA

14 Vitamins, Minerals and
200 mg of Plant-based life'sDHA™

DOCTOR-RECOMMENDED
for women planning a pregnancy,
pregnant or nursing

30 SOFTGELS
DIETARY SUPPLEMENT

Principal Display Panel - 30 Softgel Carton
PRENA1 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, zinc oxide, and doconexent capsule, gelatin coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:50265-199
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid60 mg
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol, dl- - UNII:7QWA1RIO01) .alpha.-tocopherol, dl-21 [iU]
thiamine mononitrate (UNII: 8K0I04919X) (thiamine ion - UNII:4ABT0J945J) thiamine1.5 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin1.7 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide20 mg
pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine hydrochloride25 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid400 ug
5-Methyltetrahydrofolic Acid (UNII: TYK22LML8F) (5-Methyltetrahydrofolic Acid - UNII:TYK22LML8F) 5-Methyltetrahydrofolic Acid600 ug
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin8 ug
biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04) biotin300 ug
calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737) pantothenic acid10 mg
ferrous fumarate (UNII: R5L488RY0Q) (ferrous cation - UNII:GW89581OWR) ferrous cation30 mg
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide7.5 mg
doconexent (UNII: ZAD9OKH9JC) (doconexent - UNII:ZAD9OKH9JC) doconexent200 mg
Inactive Ingredients
Ingredient NameStrength
gelatin (UNII: 2G86QN327L)  
water (UNII: 059QF0KO0R)  
yellow wax (UNII: 2ZA36H0S2V)  
glyceryl monostearate (UNII: 230OU9XXE4)  
lecithin, soybean (UNII: 1DI56QDM62)  
titanium dioxide (UNII: 15FIX9V2JP)  
tocopherol (UNII: R0ZB2556P8)  
ascorbyl palmitate (UNII: QN83US2B0N)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C red no. 40 (UNII: WZB9127XOA)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
Glycerin (UNII: PDC6A3C0OX)  
Sunflower Oil (UNII: 3W1JG795YI)  
Rosemary (UNII: IJ67X351P9)  
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize23mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:50265-199-3030 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT09/28/201202/28/2015
Labeler - BocaGreenMD Inc. (078441811)

Revised: 4/2015
 
BocaGreenMD Inc.