Prenatal

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
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  

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

Medication Information

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  

Storage

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

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.  
Precautions

Call your licensed medical practitioner about side effects.

Principal Display Panel

Structured Label Content

Storage

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

Warnings (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.  
Description (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  

Precautions (PRECAUTIONS)

Call your licensed medical practitioner about side effects.

How Supplied (HOW SUPPLIED)

Bottles of 30: 85477-922-30

Indications and Usage (INDICATIONS AND USAGE)

Prenatal and Postnatal prescriptive Folic Acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Dosage and Administration (DOSAGE AND ADMINISTRATION)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:51.689850 · Updated: 2026-03-14T22:42:04.935896