VITALARA- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, magnesium oxide tablet

VITALARA by

Drug Labeling and Warnings

VITALARA by is a Other medication manufactured, distributed, or labeled by Aletris Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

VITALARA-Dispensed by Prescription

STATEMENT OF IDENTITY

VITALARA- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, and magnesium oxide tablet.

Serving Size: 1 Tablet Servings Per Container: 30
Each Tablet Contains:		%DV
Vitamin A (as Beta-Carotene)	300 mcg RAE	23%
Vitamin C (as ascorbic acid)	60 mg	50%
Vitamin D3 (as cholecalciferol)	10 mcg	67%
Vitamin E (as dl-Alpha-Tocopheryl Acetate)	45 mg	24%
Vitamin B6 (as pyridoxine HCl)	26 mg	1300%
Folate (From Folic Acid) (From 5-Methyl Tetrahydrofolate, Calcium Salt)	1670 mcg DFE	278%
Vitamin B12 (as Cyanocobalamine)	13 mcg	464%
Biotin	28 mg	80%
Calcium (from Calcium Carbonate)	80 mg	6%
FerrochelTM Iron (as ferrous BisGlycinate Chelate)	12 mg	44%
Iodine (as potassium iodide)	150 mcg	52%
Magnesium (as Magnesium oxide)	25 mg	6%
* -Percent Daily Value for pregnant and/or lactating women

OTHER INGREDIENTS: Modified Cellulose, Stearic Acid, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polydextrose, Titanium Dioxide, FD&C #1 Blue Lake

Allergen: NONE

DESCRIPTION

VITALARA is a prescription prenatal/postnatal multivitamin/ multimineral dietary supplement.

INDICATIONS

VITALARA is a multivitamin/multimineral dietary supplement indicated for the use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers.

CONTRADINDICATIONS

VITALARA is contraindicated in patients with a 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 the case of accidental overdose, call a doctor or poison control center immediately.

ADVERSE REACTIONS

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

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact: Aletris Pharmaceuticals, LLC at 228-207-8112.

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

PRECAUTION:

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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

STORAGE

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light
and moisture.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITALARA 
beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, magnesium oxide tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	86001089074
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
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	300 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	45 mg
PYRIDOXINE HCL (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	26 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1670 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	13 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	28 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	80 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	20 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	25 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYDEXTROSE (UNII: VH2XOU12IE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	86001089074	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		12/06/2024

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
scoring	1
size (solid drugs)	19 mm

Labeler - Aletris Pharmaceuticals, LLC (118956541)

Establishment
Name	Address	ID/FEI	Business Operations
Aletris Pharmaceuticals, LLC		118956541