prenatal - DailyMed Details

prenatal

SPL v1

SPL

SPL Set ID f10bf225-c125-4711-893a-78e15be815bb

Route

oral

Published

Effective Date 2025-12-30

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

ascorbic acid (125 mg) cholecalciferol (12.5 ug) thiamine ion (1.4 mg) pyridoxal phosphate anhydrous (2.5 mg) folic acid (1 mg) methylcobalamin (1000 ug) calcium cation (200 mg) ferrous cation (13 mg) iodide ion (0.15 mg)

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 2025-12-22

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: 85477-922-30

Description

Each Tablet Contains: Amount per Tablet Vitamin C (as ascorbic acid) ............................................................................... 125 mg Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg Thiamine (as hydrochloride) ............................................................................... 1.4 mg Vitamin B6 (as pyridoxal•S•phosphate) ...................................... ....................... 2.5 mg Folic Acid ............................................................................................................ 1 mg Vitamin B12 (as methylcobalamin)...................................................................... 1,000 mcg Calcium (from calcium carbonate) ...................................................................... 200 mg Iron (as ferrous gluconate) ................................................................................. 13 mg Iodine (as potassium iodide............................................................................... 150 mcg OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract

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 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: 85477-922-30

Description

Each Tablet Contains:

Amount per Tablet

Vitamin C (as ascorbic acid) ............................................................................... 125 mg

Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg

Thiamine (as hydrochloride) ............................................................................... 1.4 mg

Vitamin B6 (as pyridoxal•S•phosphate) ...................................... ....................... 2.5 mg

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

Vitamin B12 (as methylcobalamin)...................................................................... 1,000 mcg

Calcium (from calcium carbonate) ...................................................................... 200 mg

Iron (as ferrous gluconate) ................................................................................. 13 mg

Iodine (as potassium iodide............................................................................... 150 mcg

OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract

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: 85477-922-30

Description (DESCRIPTION)