Prenate Essential

Basic Information

Product Label

Full Name: Prenate Essential

Brand: Avion Pharmaceuticals none

Product Type: Other Combinations

Physical State: Softgel Capsule

UPC/SKU: 3 75854 31330 0

Product Version Code: Rev. 0419-01

Contact Information

Manufactured for

Name: Avion Pharmaceuticals, LLC

Address:Alpharetta, GA, 30005

Phone: 1.888.612.8466

Types: Distributor

Product Details

Net Contents

30 Softgel(s)(30 Softgel(s))

Serving Sizes

Unit:Softgel(s)

Quantity:1 - 1

Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)LactatingGluten Free

Servings Per Container

Ingredients & Nutrition

Biotin

vitamin

Amount: 280 mcg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 93%

Pregnant and Lactating: 93%

Group: Biotin

Also known as: Vitamin H, Vitamin B-7, Vitamin B7, d-biotin, S. cerevisiae

UNII Code: 6SO6U10H04

Calcium

mineral

Forms:

Calcium Formate

Amount: 155 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 16%

Pregnant and Lactating: 12%

Group: Calcium

Docosahexaenoic Acid

fatty acid

Amount: 300 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: % (Daily Value (DV) Not Established)

Pregnant and Lactating: % (Daily Value (DV) Not Established)

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Eicosapentaenoic Acid

fatty acid

Amount: 40 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: % (Daily Value (DV) Not Established)

Pregnant and Lactating: % (Daily Value (DV) Not Established)

Group: EPA (Eicosapentaenoic Acid)

Also known as: C20:5n-3, EPA

UNII Code: AAN7QOV9EA

Folate

vitamin

Notes: molar equivalent to 600 mcg of folic acid

Forms:

(6S)-N5-Methyltetrahydrofolic Acid Calcium Salt

Amount: 1 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 250%

Pregnant and Lactating: 125%

Group: Vitamin B9 (Folate)

Iodine

mineral

Forms:

Potassium Iodate

Amount: 150 mcg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 100%

Pregnant and Lactating: 100%

Group: Iodine

Iron

mineral

Forms:

as Sumalate

Amount: 18 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 100%

Pregnant and Lactating: 100%

Group: Iron

Magnesium

mineral

Forms:

Magnesium Oxide

Amount: 50 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 13%

Pregnant and Lactating: 11%

Group: Magnesium

Vitamin B12

vitamin

Forms:

Cyanocobalamin

Amount: 13 mcg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 217%

Pregnant and Lactating: 163%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin

Forms:

Pyridoxine Hydrochloride

Amount: 26 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 1300%

Pregnant and Lactating: 1040%

Group: Vitamin B6

Vitamin C

vitamin

Forms:

Ascorbic Acid

Amount: 90 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 150%

Pregnant and Lactating: 150%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin

Forms:

Cholecalciferol

Amount: 220 IU

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 55%

Pregnant and Lactating: 55%

Group: Vitamin D

Also known as: Cholecalciferol, Vitashine vegan Cholecaciferol, Vitashine, Vitashine D3 Cholecalciferol, Vitashine vegan Cholecalciferol, natural Cholecalciferol, plant-based Cholecalciferol, vegan Cholecalciferol, fermented Cholecalciferol, Vitashine D3

UNII Code: 1C6V77QF41

Vitamin E

vitamin

Forms:

DL-Alpha-Tocopheryl Acetate

Amount: 10 IU

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 33%

Pregnant and Lactating: 33%

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Beeswax

animal part or source

Group: Beeswax

Cholecalciferol

vitamin

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

EPA

fatty acid

Group: EPA (Eicosapentaenoic Acid)

Also known as: Eicosapentanoic Acid, Eicosapentaenoic Acid

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Gelatin

protein

Group: Gelatin

Glycerin

other

Group: Glycerol

hydrolyzed Collagen

protein

Group: Collagen

Also known as: Gelatin

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

organic Pyridoxine

vitamin

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Sodium Copper Chlorophyllin

non-nutrient/non-botanical

Group: Chlorophyllin

UNII Code: 1D276TYV9O

Sorbitol

non-nutrient/non-botanical

Group: Sorbitol

UNII Code: 506T60A25R

Soy Lecithin

fat

Group: lecithin

Soybean Oil

fat

Group: Soybean Oil

Turmeric

botanical

Group: Turmeric

Also known as: CurcuWIN, Curcumin C3 Complex, Meriva, Curcumin

UNII Code: 856YO1Z64F

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Vitamin H

vitamin

Group: Vitamin B7 (biotin)

Also known as: Biotin

UNII Code: 6SO6U10H04

Water, Purified

other

Group: Water

UNII Code: 059QF0KO0R

Product Statements

Formula re: Contains

Rx prenatal vitamin with DHA Key vitamins, minerals, and DHA support nutrition

Formulation re: Does NOT Contain

Gluten free

FDA Statement of Identity

Rx Only Dietary Supplement

Suggested/Recommended/Usage/Directions

Dosage and Administration: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

Precautions re: Children

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. Keep out of reach of children.

Storage

Storage: Store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F) [See USP controlled room temperature.]

Formulation re: Other

Description: Prenate Essential is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with "Prenate" on one side and blank on the other.

Precautions re: Allergies

Prenate Essential contains fish oil and soy.

Formulation re: Other

Indications: Prenate Essential is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Prenate Essential can also be beneficial in improving the nutritional status of women prior to conception

Precautions re: Allergies

Contraindications: Prenate Essential is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: All Other

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 inherited or acquired predisposition to bleeding.

Precautions re: All Other

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.