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Prena1 Plus

BocaGreenMD Inc

Prena1PLUSwith Quatrefolic


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PRENA1 PLUS DESCRIPTION

Prena1 Plus is a prescription prenatal/postnatal dietary supplement containing a solid white multivitamin tablet and a red opaque softgel.

Supplement Facts

Serving Size 1 Tablet

MULTIVITAMIN/MULTIMINERAL Amount per
Tablet
% Daily Value
Pregnant and
Nursing Women
Vitamin C (as ascorbic acid) 60 mg 100%
Vitamin D3 (as cholecalciferol 600 IU 150%
Vitamin E (as dl-alpha tocopheryl acetate) 30 IU 100%
Vitamin B1 (as thiamine mononitrate) 3 mg 176%
Vitamin B2 (as riboflavin 5 phosphate sodium) 3.4 mg 170%
Vitamin B3 (as niacinamide) 20 mg 100%
Vitamin B6 (as pyridoxine HCl) 25 mg 1000%
Folate 1 mg 125%
  Quatrefolic® ((6S)-5-methyltetrahydrofolic
  acid, glucosamine salt)        600 mcg
  Folic acid                           400 mcg
Vitamin B12 (as cyanocobalamin) 12 mcg 150%
Biotin (as d-Biotin) 300 mcg 100%
Pantothenic Acid (as d-calcium pantothenate) 10 mg 100%
Calcium (as calcium carbonate) 150 mg 12%
Iron (as iron amino acid chelate) 30 mg 167%
Iodine (as potassium iodide) 150 mcg 100%
Zinc (as zinc amino acid chelate) 15 mg 100%
Copper (as copper amino acid chelate) 2 mg 100%

OTHER INGREDIENTS

Microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silicon dioxide, titanium dioxide, hypromellose, inulin, medium chained triglycerides and natural orange flavor.

Supplement Facts

Serving Size 1 Softgel

DHA Amount per
Softgel
% Daily Value
Pregnant and
Nursing Women
Calories 10
Calories from Fat 10
Total Fat 1 g
  Polyunsaturated Fat .5 g % Daily Value Not Established
DHA (docosahexaenoic acid from algal oil) 300 mg % Daily Value Not Established

OTHER INGREDIENTS

Gelatin capsule (porcine gelatin, glycerin, purified water, carmine, annatto, caramel, titanium dioxide), high oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols and ascorbyl palmitate as antioxidants.

INDICATIONS

Prena1 Plus 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 Plus can also be beneficial in improving the nutritional status of women prior to conception.

PRENA1 PLUS 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.

PRENA1 PLUS ADVERSE REACTIONS

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

PRENA1 PLUS DOSAGE AND ADMINISTRATION

As a dietary supplement for pregnant and nursing women. Take one tablet and one softgel daily with a meal. For adults only. Consult your doctor before taking any supplement.

HOW SUPPLIED

Unit dose box of 30 tablets + 30 softgels
Product Code 50265-299-60

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-0014 09/12

PRINCIPAL DISPLAY PANEL - Kit Carton

50265-299-60

Prena1
PLUS
with Quatrefolic
®

Prenatal Multivitamin
Plus DHA Softgel

Multivitamin Tablet
16 Vitamins and Minerals

DHA Softgel
300 mg of Plant-based life'sDHA™

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

30 TABLETS + 30 SOFTGELS
DIETARY SUPPLEMENT

Prena1 Plus

Prena1 Plus

ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-Methyltetrahydrofolic Acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, zinc, copper, and doconexent KIT

Product Information

Product Type Dietary supplement Item Code (Source) NDC:50265-299
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50265-299-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-09-28


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Be sure to consult your doctor before taking any medication!
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