Prenate Mini ®

Prenate Mini ®
SPL v13
SPL
SPL Set ID 8ab766c2-d554-4141-92b2-fbe038e80c9f
Route
ORAL
Published
Effective Date 2014-12-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Biotin (280 ug) Calcium Cation (80 mg) Ferrous Cation (9 mg) Iron (150 ug) Iodide Ion (25 mg) Magnesium Cation (350 mg) Doconexent (600 ug) Icosapent (60 mg) Levomefolic Acid (1000 [iU]) Ascorbic Acid (10 [iU]) Cholecalciferol (26 mg) .alpha.-tocopherol, Dl- (400 ug) Pyridoxine (13 ug) Folic Acid Cyanocobalamin
Inactive Ingredients
Fish Oil Gelatin Glycerin Lecithin, Soybean Yellow Wax Water Corn Oil Fd&c Blue No. 1 Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Imprint: Mini Shape: oval Color: green Size: 15 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2014-11-18

Description

Rx Only Dietary Supplement


Medication Information

Recent Major Changes

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Indications and Usage

INDICATIONS: PRENATE MINI ® 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.

PRENATEMINI ® can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration

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

Dosage Forms and Strengths

HOW SUPPLIED: Bottles of 30 softgels (75854-0315-30). 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 MINI ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

DESCRIPTION: PRENATE MINI ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”.

Contains fish oil and soy. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

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 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. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Section 44425-7

STORAGE: 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: Bovine gelatin, FD&C Blue #1, FD&C Yellow #5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide, vegetable shortening and yellow beeswax.

Package Label.principal Display Panel

75854-0315-30

Rx Only Dietary Supplement

Prenate mini ®

A small, easy-to-swallow

softgel with complete prenatal

nutrition support, including

350 mg of DHA

30 Softgels

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Avion

PHARMACEUTICALS


Structured Label Content

Recent Major Changes (34066-1)

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Indications and Usage (34067-9)

INDICATIONS: PRENATE MINI ® 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.

PRENATEMINI ® can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: Bottles of 30 softgels (75854-0315-30). 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 MINI ® 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 MINI ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”.

Contains fish oil and soy. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

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 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. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Section 44425-7 (44425-7)

STORAGE: 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: Bovine gelatin, FD&C Blue #1, FD&C Yellow #5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide, vegetable shortening and yellow beeswax.

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

75854-0315-30

Rx Only Dietary Supplement

Prenate mini ®

A small, easy-to-swallow

softgel with complete prenatal

nutrition support, including

350 mg of DHA

30 Softgels

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Avion

PHARMACEUTICALS


Advanced Ingredient Data


Raw Label Data

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