PreGen DHA: Package Insert and Label Information

PREGEN 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, zinc oxide, cupric oxide and fish oil capsule, gelatin coated
Emerald Therapeutics, LLC

72919-083-30

Prenatal/Postnatal/Folate Health

Dietary Supplement

Dispensed by Prescription 1


1
This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (64 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
  1. Federal Register Notice of August 2, 1973 (38 FR 20750)
  2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

Supplement Facts
Serving Size: 1 Softgel
Serving Per Container:
Amount Per Serving % Daily Value
*
Daily Values not established
Calories 5
Total Fat 0.5 g <1%
Cholesterol 25 mg 8%
Vitamin A (50% Beta-Carotene, 50% Retinyl Palmitate) 1200 mcg RAE 133%
Vitamin C (as Ascorbic Acid) 60 mg 67%
Vitamin D (as Cholecalciferol) 10 mcg 50%
Vitamin E (as d-Alpha Tocopherol) 20.1 mg 134%
Thiamin (B1) (from Thiamine Mononitrate) 1.7 mg 142%
Riboflavin (B2) 2 mg 154%
Niacin (as Niacinamide) 20 mg 125%
Vitamin B6 (from Pyridoxine Hydrochloride) 2.5 mg 147%
Folate (1000 mcg Folic Acid) 1700 mcg DFE 425%
Vitamin B12 (as Cyanocobalamin) 8 mcg 333%
Biotin 300 mcg 1000%
Pantothenic Acid (from d-Calcium Pantothenate) 10 mg 200%
Calcium (from Calcium Carbonate) 200 mg 15%
Iron (from Carbonyl Iron) 28 mg 156%
Iodine (from Potassium Iodide) 150 mcg 100%
Magnesium (from Magnesium Oxide) 50 mg 12%
Zinc (from Zinc Oxide) 15 mg 136%
Cooper (Cooper Oxide) 2 mg 222%
Eicosapentaenoic Acid (as EE) (from Fish Oil) 200 mg *
Docosahexaenoic Acid (as EE) (from Fish Oil) 35 mg *

Other Ingredients: Bovine Gelatin, Glycerin, Yellow Beeswax, Purified Water, Soy Lecithin, Annatto.

Allergens: Fish (Anchovy, Sardine, Tuna), Soy.

Does Not Contain: Peanuts, Tree Nuts, Shellfish, Eggs, Milk, Wheat.

INDICATIONS

PreGen DHA is a prescription dietary supplement for use throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PreGen DHA may be useful in improving the nutritional status of women prior to conception.

PreGen DHA is prescription dietary supplement formulated 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.

PreGen DHA is formulated as a prescription dietary supplement for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS

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

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Emerald Therapeutics, LLC at 1-800-970-1991.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Child-resistant bottles of 30 softgels (72919083-302). Softgel is oblong shaped and orange reddish in color with possible dark spots.


2
Emerald Therapeutics does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

STORAGE AND HANDLING

STORAGE

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

TAMPER EVIDENT

Do not use if seal is broken or missing.

MADE IN USA

Distributed by:
Emerald Therapeutics, LLC
Birmingham, AL 35209
800-970-1991

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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

© 2021 Emerald Therapeutics, LLC
083111-0321

PRINCIPAL DISPLAY PANEL — 30 Capsule Bottle Label

72919-083-30

PreGen DHA

PRENATAL/POSTNATAL
DIETARY SUPPLEMENT

30 SOFTGELS

Dispensed by Prescription

PRINCIPAL DISPLAY PANEL -- 30 Capsule Bottle Label
(click image for full-size original)
PREGEN 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, zinc oxide, cupric oxide, and fish oil capsule, gelatin coated
Product Information
Product Type Item Code (Source) NDC:72919-083
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Beta Carotene (Beta Carotene) Beta Carotene 600 ug
Vitamin A Palmitate (Vitamin A) Vitamin A 600 ug
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 10 ug
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 20.1 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.7 mg
Riboflavin (Riboflavin) Riboflavin 2 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 1000 ug
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 8 ug
Biotin (Biotin) Biotin 300 ug
Calcium Pantothenate (CALCIUM CATION) CALCIUM CATION 10 mg
Calcium Carbonate (CALCIUM CATION) Calcium Carbonate 200 mg
Iron (Iron) Iron 28 mg
Potassium Iodide (IODIDE ION) Potassium Iodide 150 ug
Magnesium Oxide (MAGNESIUM CATION) Magnesium Oxide 50 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 15 mg
Cupric Oxide (CUPRIC CATION) CUPRIC CATION 2 mg
Fish Oil (Fish Oil) Fish Oil 235 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin Type B Bovine (150 Bloom)
Glycerin
Yellow Wax
Water
Lecithin, Soybean
Annatto
Product Characteristics
Color ORANGE (Orange Reddish with possible dark spots) Score no score
Shape RECTANGLE (Oblong) Size 20mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72919-083-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/30/2020
Labeler — Emerald Therapeutics, LLC (116948577)

Revised: 03/2021 Emerald Therapeutics, LLC

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