Embriva Tablet
FDA Label NDC 85477-322

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Embriva (NDC 85477-322). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, warnings, precautions, dosage and administration, how supplied, storage, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Indications And Usage

→ Warnings

→ Precautions

→ Dosage And Administration

→ How Supplied

→ Storage

→ Principal Display Panel

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

Label (Embriva)

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