prenatal - DailyMed Details

prenatal

SPL v1

SPL

SPL Set ID 3c362de4-1ed9-83be-e063-6394a90a10fc

Route

oral

Published

Effective Date 2025-08-08

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

pyridoxal phosphate anhydrous (2.5 mg) iodide ion (0.15 mg) ascorbic acid (125 mg) cholecalciferol (0.0125 mg) thiamine ion (1.4 mg) folic acid (1 mg) methylcobalamin (200 mg) calcium cation (13 mg) ferrous cation

Inactive Ingredients

magnesium stearate cellulose, microcrystalline silicon dioxide

Identifiers & Packaging

Pill Appearance

Shape: oval Color: blue Size: 19 mm Score: 1

Marketing Status

unapproved drug other active Since 2025-08-08

Indications and Usage

Prenatal and Postnatal prescriptive Folic Acid

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

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

Medication Information

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.

Indications and Usage

Prenatal and Postnatal prescriptive Folic Acid

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

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

Principal Display Panel

Storage

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

Precautions

Call your licensed medical practitioner about side effects.

Structured Label Content

Warnings (WARNINGS)

Indications and Usage (INDICATIONS AND USAGE)

Prenatal and Postnatal prescriptive Folic Acid

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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

How Supplied (HOW SUPPLIED)

Bottles of 30: 85477-0322-30

Description (DESCRIPTION)