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Prena1 Chew

BocaGreenMD Inc

Prena1 Chew with Quatrefolic


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SUGGESTED USE

Prena1 Chew is a prescription prenatal/postnatal dietary supplement containing vitamins within a cream color, round tablet with orange specks.

Supplement Facts

Serving Size: 1 Chewable Tablet

MULTIVITAMIN Amount per Chewable Tablet % DV Pregnant and Nursing Women
Vitamin D3 (as cholecalciferol) 400 IU 100%
Vitamin B2 (as riboflavin) 1.7 mg 85%
Vitamin B6 (as pyridoxine HCl) 2 mg 80%
Folate 1 mg 125%
  Quatrefolic® ((6S)-5-methyltetrahydrofolic
  acid, glucosamine salt) 600 mcg
  Folic acid 400 mcg
Vitamin B12 (as methylcobalamin) 8 mcg 100%

Other Ingredients

Mannitol, natural masking flavor, natural vanilla flavor, magnesium stearate, silica.

INDICATIONS

Prena1 Chew is a dietary supplement indicated for use in improving the nutritional status of women prior to conception. Prena1 Chew can also be beneficial in improving the nutritional status of women throughout pregnancy and in the prenatal period.

PRENA1 CHEW CONTRAINDICATIONS

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

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.

PRENA1 CHEW ADVERSE REACTIONS

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

PRENA1 CHEW DOSAGE AND ADMINISTRATION

As a dietary supplement for women planning a pregnancy or pregnant women with difficulty swallowing tablets or capsules, or where nausea or morning sickness make taking tablets or capsules difficult. Take one chewable tablet daily with a meal. For adults only. Consult your doctor before taking any supplement.

HOW SUPPLIED

Unit dose box of 30 chewable tablets
Product Code 50265-399-30

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.

PRINCIPAL DISPLAY PANEL - 30 Tablet Carton

50265-399-30

Prena1
C H E W
with Quatrefolic ®

Chewable Prenatal Multivitamin

DOCTOR-RECOMMENDED
for women planning a pregnancy and
pregnant women with difficulty swallowing tablets or capsules

30 CHEWABLE TABLETS
DIETARY SUPPLEMENT

Gluten, Lactose
and Sugar-Free

Prena1 Chew

Prena1 Chew

CHOLECALCIFEROL, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, and 5-METHYLTETRAHYDROFOLIC ACID TABLET, CHEWABLE

Product Information

Product Type Dietary supplement Item Code (Source) NDC:50265-399
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
RIBOFLAVIN RIBOFLAVIN 1.7 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 2 mg
FOLIC ACID FOLIC ACID .4 ug
METHYLCOBALAMIN METHYLCOBALAMIN 8 ug
5-METHYLTETRAHYDROFOLIC ACID 5-Methyltetrahydrofolic Acid .6 ug

Inactive Ingredients

Ingredient Name Strength
mannitol
MAGNESIUM STEARATE
SILICON DIOXIDE

Product Characteristics

Color Size Shape
WHITE 10 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BLISTER PACK
2 NDC:50265-399-30 1 in 1 BOX, UNIT-DOSE

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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