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Embriva Package Insert

Status:
Prescription (Rx) Facts
Strength:
2.5 mg, 0.15 mg, 125 mg, 0.0125 mg, 1.4 mg, 1 mg, 1 mg, 200 mg, 13 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Embriva

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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Embriva

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Blood Coagulation Factor, Phosphate Binder, Vitamin C, Vitamin D
Active ingredients Pyridoxal phosphate anhydrous 2.5 mg, Potassium iodide 0.15 mg, Ascorbic acid 125 mg, Cholecalciferol 0.0125 mg, Thiamine 1.4 mg, Folic acid 1 mg, Methylcobalamin 1 mg, Calcium carbonate 200 mg, Ferrous gluconate 13 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Oncora Pharma, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2.5 mg, 0.15 mg, 125 mg, 0.0125 mg, 1.4 mg, 1 mg, 1 mg, 200 mg, 13 mg – 30 in 1 bottle, plastic NDC 85477-322-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.