Prenate Elite

Drug Facts

Composition & Product

Active Ingredients

.beta.-carotene (2600 [iU]) Ascorbic Acid (75 mg) Cholecalciferol (600 [iU]) .alpha.-tocopherol, Dl- (40 [iU]) Riboflavin (3 mg) Niacinamide (3.5 mg) Pyridoxine (21 mg) Folic Acid (400 ug) 5-methyltetrahydrofolic Acid (600 ug) Calcium Cation (155 mg) Ferrous Cation (20 mg) Cyanocobalamin (13 ug) Biotin (330 ug) Iodide Ion (150 ug) Magnesium Cation (25 mg) Zinc Cation (15 mg) Cupric Cation (1.5 mg)

Inactive Ingredients

Powdered Cellulose Silicon Dioxide Croscarmellose Sodium Stearic Acid Magnesium Stearate Hypromelloses Triacetin Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PN Shape: oval Color: white Size: 20 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2014-06-05

Medication Information

Recent Major Changes

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.

Indications and Usage

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.

Dosage and Administration

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

Dosage Forms and Strengths

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Contraindications

CONTRAINDICATIONS: PRENATE ELITE ^® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

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.

Section 34084-4

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

Section 42229-5

Rx Only Dietary Supplement

Section 42232-9

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B ₁₂ 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.

Section 44425-7

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

Section 51727-6

OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Triacetin, Titanium Dioxide).

Package Label.principal Display Panel

75854-314-30

Prenate Elite ^®

PRENATAL VITAMINS-FILM-COATED TABLETS

GLUTEN FREE

Rx Only

Dietary Supplement

30 Tablets

Structured Label Content

Recent Major Changes (34066-1)

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.

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Contraindications (34070-3)

CONTRAINDICATIONS: PRENATE ELITE ^® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Section 34084-4 (34084-4)

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

Description (34089-3)

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.

Section 42229-5 (42229-5)

Rx Only Dietary Supplement

Section 42232-9 (42232-9)

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B ₁₂ 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.

Section 44425-7 (44425-7)

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

Section 51727-6 (51727-6)

OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Triacetin, Titanium Dioxide).

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

75854-314-30

Prenate Elite ^®

PRENATAL VITAMINS-FILM-COATED TABLETS

GLUTEN FREE

Rx Only

Dietary Supplement

30 Tablets

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34066-1": "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.", "34067-9": "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.", "34068-7": "DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.", "34069-5": "HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.", "34070-3": "CONTRAINDICATIONS: PRENATE ELITE ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.", "34084-4": "ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.", "34089-3": "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.", "42229-5": "Rx Only Dietary Supplement", "42232-9": "PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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.", "44425-7": "Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]", "51727-6": "OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Triacetin, Titanium Dioxide).", "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "75854-314-30 Prenate Elite ® PRENATAL VITAMINS-FILM-COATED TABLETS GLUTEN FREE Rx Only Dietary Supplement 30 Tablets"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information