EMBRIVA- ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet

Embriva by

Drug Labeling and Warnings

Embriva by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Each Tablet Contains:

Amount per Tablet

Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg

Ascorbic Acid...................... ......................................................... 125 mg

Folic Acid ....................................................................................... 1 mg

Colecalciferol ............................................................................. .0125 mg

Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg

Methylcobalamin.................. ........................................................ 1 mg

Calcium Carbonate ................................................................... 200 mg

Ferrous Gluconate ..................................................................... 13 mg

Potassium Iodide........................................................................ .15 mg

Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide

INDICATIONS AND USAGE

Prenatal and Postnatal prescriptive Folic Acid

WARNINGS

WARNING:  Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. 

PRECAUTIONS

Call your licensed medical practitioner about side effects.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner.

HOW SUPPLIED

Bottles of 30: 85477-0322-30

Storage

KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EMBRIVA 
ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6)	PYRIDOXAL PHOSPHATE ANHYDROUS	2.5 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	0.15 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	0.0125 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.4 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	1 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	13 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-322-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/08/2025

Labeler - Oncora Pharma, LLC (119482542)