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Gestyra Package Insert

Status:
Prescription (Rx) Facts
Strength:
125 mg, 12.5 mcg, 1.4 mg, 2.5 mg, 1 mg, 1000 mcg, 200 mg, 13 mg, 0.15 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Gestyra

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

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.

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

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 Gestyra

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 Ascorbic acid 125 mg, Cholecalciferol 12.5 mcg, Thiamine 1.4 mg, Pyridoxal phosphate anhydrous 2.5 mg, Folic acid 1 mg, Methylcobalamin 1000 mcg, Calcium carbonate 200 mg, Ferrous gluconate 13 mg, Potassium iodide 0.15 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
125 mg, 12.5 mcg, 1.4 mg, 2.5 mg, 1 mg, 1000 mcg, 200 mg, 13 mg, 0.15 mg – 30 in 1 bottle, plastic NDC 85477-922-30

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.