PRENYRA tablet

Drug Labeling and Warnings

Drug Details [pdf]

Health Claim

Prenyra Tablets - Prenatal/Postnatal/Folate Health Dietary Supplement     

Dispensed by Prescription

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Description

Prenyra Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status
in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

Warnings

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

 CONTRAINDICATIONS: Prenyra Tablets are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Precaution

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Prenyra Tablets should only be used under the direction and supervision of a licensed medical practitioner.

For external use only

Dosage & Administration

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

STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture.

Tamper Evident: Do not use if seal is broken or missing.

Manufacturered for:

Oncora Pharma LLC

Dallas TX 75228

Principal Display Panel

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INGREDIENTS AND APPEARANCE

PRENYRA 
prenyra tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:85477-923
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	.0125 mg
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	1.4 mg
PYRIDOXAL 5-PHOSPHATE (UNII: F06SGE49M6) (PYRIDOXAL 5-PHOSPHATE - UNII:F06SGE49M6)	PYRIDOXAL 5-PHOSPHATE	2.5 mg
IODIDE ION (UNII: 09G4I6V86Q) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	.15 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	1 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	13 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	13 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICA (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:85477-923-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		04/01/2026

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	19 mm

Labeler - Oncora Pharma, LLC (119482542)

Registrant - Solubiomix (079640556)