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

Product Version Code: L-0187 Rev 0620-01

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

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

Calcium

mineral

Forms:

Calcium Formate

Amount: 155 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 20%

Pregnant and Lactating: 10%

Group: Calcium

Copper

mineral

Forms:

Copper 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: 1700 mcg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 430%

Pregnant and Lactating: 280%

Group: Vitamin B9 (Folate)

Iodine

mineral

Forms:

Potassium Iodine

Amount: 150 mcg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 100%

Group: Iodine

Iron

mineral

Forms:

as Ferrous Asparto Glycinate

Amount: 20 mg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 110%

Group: Iron

Magnesium

mineral

Forms:

Magnesium Oxide

Amount: 25 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 10%

Pregnant and Lactating: 10%

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: 210%

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

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: 180%

Group: Thiamin

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

UNII Code: X66NSO3N35

Vitamin A

vitamin

Forms:

Beta-Carotene

Amount: 780 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 90%

Pregnant and Lactating: 90%

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: 220%

Pregnant and Lactating: 160%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin

Notes: Vitamin B6 (Form: as Pyridoxine HCl)

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: 15 mcg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 75%

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: 18 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 120%

Pregnant and Lactating: 120%

Group: Vitamin E

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

UNII Code: H4N855PNZ1

Zinc

mineral

Notes: Zinc (Form: as Zinc Oxide)

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

Cholecalciferol

vitamin

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Croscarmellose Sodium

other

Group: Croscarmellose Sodium

Film Coating

other

Group: Coating

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

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

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

Rx only 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.

Formulation re: Does NOT Contain

Contains no ingredient made from gluten-containing grain (wheat, barley, or rye).

Formula re: Type

Indications: Prenate Elite is a multivitamin/multimineral 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: All Other

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.

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 the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions re: Allergies

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

Suggested/Recommended/Usage/Directions

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

General Statements: All Other Content

How supplied: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

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.]

FDA Disclaimer Statement

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.

Brand IP Statement(s) re: (c), (TM), (SM)

Formical is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. patent no. 6,528,542. Sumalate is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. patent nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.