VITAMEDMD RX 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, ferrous bisglycinate hydrochloride, potassium iodide, zinc glycinate, copper, and doconexent kit

vitaMedMD by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

vitaMedMD™ Plus Rx 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
* % Daily Value Not Established
Calories	10
Calories from Fat	10
Total Fat	1 g	100%
Polyunsaturated Fat	.5 g	*
DHA (docosahexaenoic acid from algal oil)	300 mg	*

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

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

HOW SUPPLIED

Unit dose box of 30 softgels + 30 tablets
Product Code 10782-201-60

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.

PLRX-0008 01/12

PRINCIPAL DISPLAY PANEL - 30 Tablet + 30 Softgel Bottle Carton

Product Code 10782-201-60

vitaMedMD™

Plus Rx 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

TherapeuticsMD™

30 TABLETS + 30 SOFTGELS
DIETARY SUPPLEMENT

INGREDIENTS AND APPEARANCE

VITAMEDMD   RX 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, ferrous bisglycinate hydrochloride, potassium iodide, zinc glycinate, copper, and doconexent kit

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:10782-201

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:10782-201-60	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	30
Part 2	1 BLISTER PACK	30

Part 1 of 2

PRENATAL MULTIVITAMIN 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous bisglycinate hydrochloride, potassium iodide, zinc glycinate, and copper tablet

Product Information
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	600 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol, dl- - UNII:7QWA1RIO01)	.alpha.-tocopherol acetate, dl-	30 [iU]
thiamine mononitrate (UNII: 8K0I04919X) (thiamine ion - UNII:4ABT0J945J)	thiamine mononitrate	3 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR)	riboflavin	3.4 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4)	niacinamide	20 mg
pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z)	pyridoxine hydrochloride	25 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8)	folic acid	400 ug
5-methyltetrahydrofolic acid (UNII: TYK22LML8F) (5-methyltetrahydrofolic acid - UNII:TYK22LML8F)	5-methyltetrahydrofolic acid	600 ug
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204)	cyanocobalamin	12 ug
biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04)	biotin	300 ug
calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737)	calcium pantothenate	10 mg
calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB)	calcium carbonate	150 mg
ferrous bisglycinate hydrochloride (UNII: IW3QLZ8MRC) (ferrous cation - UNII:GW89581OWR)	ferrous bisglycinate hydrochloride	30 mg
potassium iodide (UNII: 1C4QK22F9J) (iodide ion - UNII:09G4I6V86Q)	potassium iodide	150 ug
zinc glycinate (UNII: 681VJX72FE) (zinc cation - UNII:13S1S8SF37)	zinc glycinate	15 mg
copper (UNII: 789U1901C5) (copper - UNII:789U1901C5)	copper	2 mg

Inactive Ingredients
Ingredient Name	Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
stearic acid (UNII: 4ELV7Z65AP)
croscarmellose sodium (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
silicon dioxide (UNII: ETJ7Z6XBU4)
titanium dioxide (UNII: 15FIX9V2JP)
hypromelloses (UNII: 3NXW29V3WO)
inulin (UNII: JOS53KRJ01)
medium-chain triglycerides (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		03/01/2012

Part 2 of 2

DHA SOFTGEL 
doconexent capsule, gelatin coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
doconexent (UNII: ZAD9OKH9JC) (doconexent - UNII:ZAD9OKH9JC)	doconexent	300 mg

Inactive Ingredients
Ingredient Name	Strength
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
annatto (UNII: 6PQP1V1B6O)
caramel (UNII: T9D99G2B1R)
titanium dioxide (UNII: 15FIX9V2JP)
tocopherol (UNII: R0ZB2556P8)
ascorbyl palmitate (UNII: QN83US2B0N)
sunflower oil (UNII: 3W1JG795YI)
rosemary (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		03/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		03/01/2012

Labeler - vitaMedMD (019920270)

Establishment
Name	Address	ID/FEI	Business Operations
vitaMedMD		019920270	MANUFACTURE(10782-201)