GESTYRA- ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet

Gestyra by

Drug Labeling and Warnings

Gestyra by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 pyridoxalSphosphate) ...................................... ....................... 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GESTYRA 
ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-922
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	12.5 ug
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.4 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6)	PYRIDOXAL PHOSPHATE ANHYDROUS	2.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	1000 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	13 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	0.15 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-922-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/22/2025

Labeler - Oncora Pharma LLC (119482542)