Prenate Elite

Basic Information

Product Label

Full Name: Prenate Elite

Brand: Avion Pharmaceuticals none

Product Type: Other Combinations

Physical State: Tablet or Pill

Product Version Code: Rev. 022012

Contact Information

MANUFACTURED FOR

Name: Avion Pharmaceuticals, LLC

Address:Atlanta, GA, 30350

Phone: 1-888-612-8466

Types: Distributor

Product Details

Net Contents

N/A(0 Not Present)

Serving Sizes

Unit:Tablet(s)

Quantity:1 - 1

Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

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

Notes: Calcium (Form: as Calcium Carbonate)

Forms:

Calcium Carbonate

Amount: 100 mg

Serving Size: 1 Tablet(s)

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

Pregnant and Lactating: 8%

Group: Calcium

Copper

mineral

Notes: Copper (Form: as Copper Oxide)

Forms:

as 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: 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)

Iodine

mineral

Notes: Iodine (Form: as Potassium Iodine)

Forms:

as 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

Notes: Iron (Form: as Ferrous Fumarate)

Forms:

as Ferrous Fumarate

Amount: 26 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 144%

Pregnant and Lactating: 144%

Group: Iron

Magnesium

mineral

Notes: Magnesium (Form: as Magnesium Oxide)

Forms:

as 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

Niacin

vitamin

Notes: Niacin (Form: as Niacinamide)

Forms:

Niacinamide

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, Vit. B-3, B3, Niacinol, Nicotinic Acid, B-3, Vitamin B-3

UNII Code: 2679MF687A

Pantothenic Acid

vitamin

Notes: Pantothenic Acid (Form: as Calcium Pantothenate)

Forms:

Calcium Pantothenate

Amount: 6 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 60%

Pregnant and Lactating: 60%

Group: Vitamin B5 (Pantothenic Acid)

Also known as: Vitamin B5, Vitamin B-5, B5, B-5

UNII Code: 19F5HK2737

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

Thiamine

vitamin

Notes: Thiamin (Form: as Thiamin Mononitrate)

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

Notes: Vitamin A (Form: as 100% Beta-Carotene)

Forms:

Beta-Carotene

Amount: 2600 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 50%

Pregnant and Lactating: 33%

Group: Vitamin A (unspecified)

Vitamin B12

vitamin

Notes: Vitamin B12 (Form: as Cyanocobalamin)

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

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: 450 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 113%

Pregnant and Lactating: 113%

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

Notes: Vitamin E (Form: as DL-Alpha Tocopheryl Acetate)

Forms:

DL-Alpha-Tocopheryl Acetate

Amount: 10 IU

Serving Size: 1 Tablet(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

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

(6S)-5-Methylfolate

vitamin

Group: Vitamin B9 (5-Methyltetrahydrofolate)

Also known as: Quatrefolic

aqueous coating

other

Group: Coating

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

Dicalcium Phosphate

mineral

Group: Calcium

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

Quatrefolic

non-nutrient/non-botanical

Group: 5-methyltetrahydrofolate glucosamine

Also known as: (6S)-5-Methylfolate, (6S)-5-MTHF

UNII Code: Q65PL71Q1A

Silica

mineral

Group: Silicon

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Titanium Dioxide

other

Group: Titanium Dioxide

Vit. B1

vitamin

Group: Vitamin B1 (unspecified)

Also known as: Thiamine

Vit. B2

vitamin

Group: Vitamin B2 (unspecified)

Also known as: Riboflavin

Vit. B5

vitamin

Group: Vitamin B5 (unspecified)

Also known as: Pantothenic Acid

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

Formula re: Type

INDICATIONS: PRENATE ELITE(R) 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. PRENATE ELITE(R) can also be beneficial in improving the nutritional status of women prior to conception.

Precautions re: All Other

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

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

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

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

Formula re: Type

PRENATAL VITAMINS-FILM COATED TABLETS

Formula re: Contains

With Quatrefolic(R)

General Statements: All Other Content

Rx Only

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

DESCRIPTION: PRENATE ELITE(R) is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "PN" on one side and blank on the other.

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Precautions re: Allergies

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

General Statements: All Other Content

HOW SUPPLIED: PRENATE ELITE(R) is supplied in child-resistant bottles of 90 tablets (75854-301-90). 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.