Prenate Elite

Basic Information

Product Label

Full Name: Prenate Elite

Brand: Avion Pharmaceuticals none

Product Type: Multi-Vitamin and Mineral (MVM)

Physical State: Tablet or Pill

UPC/SKU: 3 75854 31430 7

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 Tablet(s)(30 Tablet(s))

Serving Sizes

Unit:Tablet(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: 330 mcg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 110%

Pregnant and Lactating: 110%

Group: Biotin

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

UNII Code: 6SO6U10H04

Copper

mineral

Forms:

Cupric Oxide

Amount: 1.5 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 75%

Pregnant and Lactating: 75%

Group: Copper

Folate

vitamin

Amount: 1 mg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 125%

Group: Vitamin B9 (Folate)

Formical

other

Forms:

Calcium Formate

Amount: 155 mg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 12%

Group: Calcium Formate

Iodine

mineral

Forms:

Potassium Iodide

Amount: 150 mcg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 100%

Group: Iodine

Magnesium

mineral

Forms:

Magnesium Oxide

Amount: 25 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 6%

Pregnant and Lactating: 6%

Group: Magnesium

Niacinamide

vitamin

Amount: 21 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 105%

Pregnant and Lactating: 105%

Group: Niacin

Also known as: Vitamin B3, B3

UNII Code: 25X51I8RD4

Riboflavin

vitamin

Amount: 3.5 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 206%

Pregnant and Lactating: 175%

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B-2, vitamin B2, Vitamin B2, B2, activated B2, B-2, Vit. B2, pure powder B-2

UNII Code: TLM2976OFR

Sumalate

non-nutrient/non-botanical

Forms:

Iron

Amount: 20 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 111%

Pregnant and Lactating: 111%

Group: Iron

Also known as: elemental Iron

Thiamine

vitamin

Forms:

Thiamine Mononitrate

Amount: 3 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 200%

Pregnant and Lactating: 176%

Group: Thiamin

Also known as: Vitamin B1, B1, Vitamin B-1, B-1

UNII Code: X66NSO3N35

Vitamin A

vitamin

Forms:

Beta-Carotene

Amount: 2600 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 52%

Pregnant and Lactating: 33%

Group: Vitamin A (unspecified)

Vitamin B12

vitamin

Forms:

Cyanocobalamin

Amount: 13 mcg

Serving Size: 1 Tablet(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: 21 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 1050%

Pregnant and Lactating: 840%

Group: Vitamin B6

Vitamin C

vitamin

Forms:

Ascorbic Acid

Amount: 75 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 125%

Pregnant and Lactating: 125%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin

Forms:

Cholecalciferol

Amount: 600 IU

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 150%

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: 40 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 133%

Pregnant and Lactating: 133%

Group: Vitamin E

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

UNII Code: H4N855PNZ1

Zinc

mineral

Forms:

Zinc Oxide

Amount: 15 mg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 100%

Group: Zinc

Beta-Carotene

vitamin

Group: Vitamin A

Also known as: Betatene, Vitamin A

UNII Code: 01YAE03M7J

Calcium

mineral

Group: Calcium

Also known as: Ca, AlgaeCal Select, AlgaeCal, DimaCal, Advan-C, Formical, Ca., DimaCal Di-Calcium Malate, AlgaeCal(R), Ana-Cal

UNII Code: SY7Q814VUP

Cholecalciferol

vitamin

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Croscarmellose Sodium

other

Group: Croscarmellose Sodium

elemental Iron

mineral

Group: Iron

Also known as: Sumalate

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

Glyceryl Triacetate

non-nutrient/non-botanical

Group: Triacetin

Also known as: Triacetin

HPMC

other

Group: Hypromellose

Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose

Hydroxypropyl Methylcellulose

other

Group: Hypromellose

Magnesium Stearate

other

Group: Magnesium stearate

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Microcrystalline Cellulose

other

Group: Cellulose

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

Silicon Dioxide

mineral

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Titanium Dioxide

other

Group: Titanium Dioxide

Triacetin

non-nutrient/non-botanical

Group: Triacetin

Vit. B1

vitamin

Group: Vitamin B1 (unspecified)

Also known as: Thiamine

Vit. B2

vitamin

Group: Vitamin B2 (unspecified)

Also known as: Riboflavin

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

Product Statements

Formulation re: Other

Prenatal Vitamins - Film - Coated tablets

Formulation re: Does NOT Contain

Gluten free

FDA Statement of Identity

Dietary Supplement

Suggested/Recommended/Usage/Directions

Dosage and Administration: Before, during and/or after pregnancy, one tablet 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.]

Formula re: Contains

Description: Prenate Elite is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "PN" on one side and blank on the other.

Formula re: Contains

Indications: Prenate Elite 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.

Precautions re: Allergies

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

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.