Prenate

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (500 mg) Cholecalciferol (300 [iU]) Magnesium Cation (50 mg) Boron (250 ug) Folic Acid (1 mg) Pyridoxine (10 mg) Cyanocobalamin (125 mg) Biotin (280 ug) Bilberry (25 mg)

Inactive Ingredients

Fructose Acacia Magnesium Stearate Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PrenateChew Shape: round Color: brown Size: 22 mm Score: 2

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2013-01-16

Medication Information

Indications and Usage

INDICATIONS: PRENATE CHEWABLE ^® 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 CHEWABLE ^™ can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration

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

Dosage Forms and Strengths

HOW SUPPLIED: PRENATE CHEWABLE ^® is supplied in child-resistant bottles of 30 tablets (75854-306-30).

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.

Contraindications

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

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

Description

DESCRIPTION: PRENATE CHEWABLE ^® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" 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

A chewable Rx prenatal vitamin with a delicious chocolate flavor

Rx Only

Section 42232-9

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.

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: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ^®), and Hydrogenated Vegetable Oil (as Sterotex ^®).

Section 51945-4

75854-306-30

Prenate chewable ^®

A chewable Rx prenatal vitamin with a delicious chocolate flavor

with Quatrefolic®

Dietary Supplement

30 Tablets

Rx Only

Avion

PHARMACEUTICALS

Structured Label Content

Indications and Usage (34067-9)

INDICATIONS: PRENATE CHEWABLE ^® 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 CHEWABLE ^™ can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: PRENATE CHEWABLE ^® is supplied in child-resistant bottles of 30 tablets (75854-306-30).

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.

Contraindications (34070-3)

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

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

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 CHEWABLE ^® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other.

Section 42229-5 (42229-5)

A chewable Rx prenatal vitamin with a delicious chocolate flavor

Rx Only

Section 42232-9 (42232-9)

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.

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: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ^®), and Hydrogenated Vegetable Oil (as Sterotex ^®).

Section 51945-4 (51945-4)

75854-306-30

Prenate chewable ^®

A chewable Rx prenatal vitamin with a delicious chocolate flavor

with Quatrefolic®

Dietary Supplement

30 Tablets

Rx Only

Avion

PHARMACEUTICALS

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "INDICATIONS: PRENATE CHEWABLE ® 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 CHEWABLE ™ can also be beneficial in improving the nutritional status of women prior to conception.", "34068-7": "DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.", "34069-5": "HOW SUPPLIED: PRENATE CHEWABLE ® is supplied in child-resistant bottles of 30 tablets (75854-306-30). 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.", "34070-3": "CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.", "34084-4": "ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.", "34089-3": "DESCRIPTION: PRENATE CHEWABLE ® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other.", "42229-5": "A chewable Rx prenatal vitamin with a delicious chocolate flavor Rx Only", "42232-9": "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.", "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: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ® ), and Hydrogenated Vegetable Oil (as Sterotex ® ).", "51945-4": "75854-306-30 Prenate chewable ® A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic® Dietary Supplement 30 Tablets Rx Only Avion PHARMACEUTICALS"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information