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vitaMedMD One Rx

vitaMedMD

vitaMed MD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

VITAMEDMD ONE RX DESCRIPTION

vitaMedMD™ One Rx 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/MULTIMINERAL Amount per softgel % Daily Value Pregnant and Nursing Women
Vitamin C (as ascorbic acid) 60 mg 100%
Vitamin D3 (as cholecalciferol) 400 IU 100%
Vitamin E (as dl-alpha tocopheryl acetate) 21 IU 70%
Vitamin B1 (as thiamine mononitrate) 1.5 mg 88%
Vitamin B2 (as riboflavin) 1.7 mg 85%
Vitamin B3 (as niacinamide) 20 mg 100%
Vitamin B6 (as pyridoxine HCI) 25 mg 1000%
Folate 1 mg 125%
  Quatrefolic®((6S)-5-methyltetrahydrofolic
  acid, glucosamine salt)        600 mcg
  Folic acid                               400 mcg
Vitamin B12 (as cyanocobalamin) 8 mcg 100%
Biotin (as d-Biotin) 300 mcg 100%
Pantothenic Acid (as d-calcium pantothenate) 10 mg 100%
Iron (as ferrous fumerate) 30 mg 167%
Zinc (as zinc oxide) 7.5 mg 50%
DHA (docosahexaenoic acid from algal oil) 200 mg % Daily Value Not Established

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

vitaMedMD™ One Rx 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. vitaMedMD™ One Rx can also be beneficial in improving the nutritional status of women prior to conception.

VITAMEDMD ONE RX 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 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.

VITAMEDMD ONE RX ADVERSE REACTIONS

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

VITAMEDMD ONE RX 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 10782-101-30

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

Marketed and Distributed by: TherapeuticsMD
951 Broken Sound Parkway NW, #320, Boca Raton, Florida 33487
800.728.0009 www.TherapeuticsMD.com

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

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Carton

Product Code 10782-101-30

vitaMedMD

One Rx 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

TherapeuticsMD

30 SOFTGELS
DIETARY SUPPLEMENT

vitaMedMD One Rx

vitaMedMD One Rx

ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, 5-METHYLTETRAHYDROFOLIC ACID, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, zinc oxide, and doconexent CAPSULE, GELATIN COATED

Product Information

Product Type Dietary supplement Item Code (Source) NDC:10782-101
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 60 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 21 [iU]
THIAMINE MONONITRATE THIAMINE ION 1.5 mg
RIBOFLAVIN RIBOFLAVIN 1.7 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 25 mg
5-METHYLTETRAHYDROFOLIC ACID 5-Methyltetrahydrofolic Acid 600 ug
FOLIC ACID FOLIC ACID 400 ug
Cyanocobalamin CYANOCOBALAMIN 8 ug
BIOTIN 300 ug
CALCIUM PANTOTHENATE PANTOTHENIC ACID 10 mg
FERROUS FUMARATE FERROUS CATION 30 mg
Zinc Oxide Zinc oxide 7.5 mg
DOCONEXENT DOCONEXENT 200 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
water
YELLOW WAX
GLYCERYL MONOSTEARATE
LECITHIN, SOYBEAN
titanium dioxide
Tocopherol
ASCORBYL PALMITATE
D&C RED NO. 33
FD&C RED NO. 40
FD&C BLUE NO. 1
GLYCERIN
SUNFLOWER OIL
ROSEMARY

Product Characteristics

Color Size Shape
PURPLE 23 mm CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10782-101-30 30 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-04-15


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