Dosage and administration
Usual adult dose is 1 capsule by mouth daily once daily, or as prescribed by a licensed medical practitioner.
FolaSync DHA
- Manufacturer
- Blue Heron Pharmaceuticals, LLC
- Effective date
- 2026-01-12
- Label type
- DIETARY SUPPLEMENT
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:52:18
Label at a glance#
ProductFolaSync DHA
Active ingredientBETA 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, Fish Oil
Label structure7 sections
Label contents#
Full prescribing information#
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:
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 85622-0051-30 | Folasync Label_v2.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85622-051-30 | FolaSync DHA | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85622-051-30 | EA - Each | 85622-051 | 153f5f38-4a1f-4375-a88d-1c1e891d5039 | 1 | 2026-01-08 |
Products#
Every source-derived product name is available through these pages.
- 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
- BETA CAROTENE
- Vitamin A Palmitate
- Retinol
- Ascorbic Acid
- Cholecalciferol
- .ALPHA.-TOCOPHEROL, D-
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- Riboflavin
- Niacinamide
- Pyridoxine Hydrochloride
- PYRIDOXINE
- Folic Acid
- Cyanocobalamin
- Biotin
- Calcium Pantothenate
- PANTOTHENIC ACID
- Calcium Carbonate
- Calcium Cation
- Iron
- Potassium Iodide
- IODIDE ION
- Magnesium Oxide
- MAGNESIUM CATION
- Fish Oil
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85622-051 | 85622-051-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BETA CAROTENE | 01YAE03M7J | ACTIB |
| Vitamin A Palmitate | 1D1K0N0VVC | ACTIM |
| Ascorbic Acid | PQ6CK8PD0R | ACTIB |
| Cholecalciferol | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL, D- | N9PR3490H9 | ACTIB |
| THIAMINE MONONITRATE | 8K0I04919X | ACTIR |
| Riboflavin | TLM2976OFR | ACTIB |
| Niacinamide | 25X51I8RD4 | ACTIB |
| Pyridoxine Hydrochloride | 68Y4CF58BV | ACTIB |
| Folic Acid | 935E97BOY8 | ACTIB |
| Cyanocobalamin | P6YC3EG204 | ACTIB |
| Biotin | 6SO6U10H04 | ACTIB |
| Calcium Pantothenate | 568ET80C3D | ACTIM |
| Calcium Carbonate | H0G9379FGK | ACTIB |
| Iron | E1UOL152H7 | ACTIB |
| Potassium Iodide | 1C4QK22F9J | ACTIB |
| Magnesium Oxide | 3A3U0GI71G | ACTIB |
| Fish Oil | XGF7L72M0F | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-10-09 | monthly-update | 2026-06-03 17:40:55 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.