FOLASYNC DHA- beta carotene, vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, and fish oil capsule, gelatin coated

FolaSync DHA by

Drug Labeling and Warnings

FolaSync DHA by is a Other medication manufactured, distributed, or labeled by Blue Heron Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Claim:

FolaSync DHA

Description:

FolaSync DHA Capsules are clear capsules dispensed in plastic bottles of 30 ct.

85622-0051-30

Reserved for Professional Recommendation

FolaSync DHA Capsules are an orally administered prescription vitamin to provide significant amounts of DHA, Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, thiamine monoitrate, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamines will not develop.

FolaSync DHA Capsules should be administered under the supervision of a licensed medical practitioner.

This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

Blue Heron Pharmaceuticals

Lutz, FL 33559

Warnings:

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

FolaSync DHA Capsules should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Precautions:

CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

Dosage and Administration:

Usual adult dose is 1 capsule by mouth daily once daily, or as prescribed by a licensed medical practitioner.

Storage:

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

Label:

INGREDIENTS AND APPEARANCE

FOLASYNC DHA 
beta carotene, vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, and fish oil capsule, gelatin coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:85622-051
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	600 ug
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Retinol - UNII:G2SH0XKK91)	Retinol	600 ug
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	10 ug
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	20.1 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.7 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	2 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1000 ug
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	8 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	300 ug
Calcium Pantothenate (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	10 mg
Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Carbonate	200 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	18 mg
Potassium Iodide (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	Potassium Iodide	150 ug
Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	Magnesium Oxide	50 mg
Fish Oil (UNII: XGF7L72M0F) (Fish Oil - UNII:XGF7L72M0F)	Fish Oil	150 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:85622-051-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		10/09/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	25 mm

Labeler - Blue Heron Pharmaceuticals, LLC (137019051)