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

vitaMedMD One Rx by

Drug Labeling and Warnings

vitaMedMD One Rx by is a Other medication manufactured, distributed, or labeled by vitaMedMD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
* % Daily Value Not Established
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	*

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.

CONTRAINDICATIONS

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

WARNINGS

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.

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 10782-101-30

SAFE HANDLING WARNING

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

STATEMENT OF IDENTITY

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

INGREDIENTS AND APPEARANCE

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)	NHRIC:10782-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R)	ascorbic acid	60 mg
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41)	cholecalciferol	400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol, dl- - UNII:7QWA1RIO01)	.alpha.-tocopherol acetate, dl-	21 [iU]
thiamine mononitrate (UNII: 8K0I04919X) (thiamine ion - UNII:4ABT0J945J)	thiamine mononitrate	1.5 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR)	riboflavin	1.7 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4)	niacinamide	20 mg
pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z)	pyridoxine hydrochloride	25 mg
5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F)	5-METHYLTETRAHYDROFOLIC ACID	600 ug
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8)	folic acid	400 ug
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204)	cyanocobalamin	8 ug
biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04)	biotin	300 ug
calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737)	calcium pantothenate	10 mg
ferrous fumarate (UNII: R5L488RY0Q) (ferrous cation - UNII:GW89581OWR)	ferrous fumarate	30 mg
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	7.5 mg
doconexent (UNII: ZAD9OKH9JC) (doconexent - UNII:ZAD9OKH9JC)	doconexent	200 mg

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		04/15/2012

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	23 mm

Labeler - vitaMedMD (019920270)

Establishment
Name	Address	ID/FEI	Business Operations
vitaMedMD		019920270	MANUFACTURE(10782-101)