Prenate Pixie ®

Prenate Pixie ®
SPL v12
SPL
SPL Set ID fe0a737e-4f28-40d8-b4a7-090edf86a823
Route
ORAL
Published
Effective Date 2025-05-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (30 mg) Biotin (75 ug) Cholecalciferol (12.5 ug) Cyanocobalamin (13 ug) Folic Acid (400 ug) Ferrous Cation (10 mg) Iodide Ion (150 ug) Pyridoxine (5 mg) .alpha.-tocopherol, Dl- (4.5 mg) Blueberry (200 mg) Doconexent (600 ug) Levomefolic Acid
Inactive Ingredients
Glycerin Lecithin, Soybean Water Titanium Dioxide Fd&c Red No. 40 Caramel Fd&c Blue No. 1 Gelatin Beeswax Palm Shortening

Identifiers & Packaging

Pill Appearance
Imprint: PIX Shape: oval Color: purple Size: 22 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2014-08-15

Description

Rx Only Dietary Supplement DESCRIPTION: PRENATE PIXIE ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ® contains no ingredient made from gluten-containing grain (wheat, barley, or rye)


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 PIXIE ®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 softgel daily or as directed by a physician.

Dosage Forms and Strengths

HOW SUPPLIED:Bottles of 30 softgels (75854-0316-30). 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 PIXIE ®is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

Rx Only Dietary Supplement

DESCRIPTION:PRENATE PIXIE ®is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ®contains no ingredient made from gluten-containing grain (wheat, barley, or rye)

Section 34084-4

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

Section 42229-5

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.

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

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.

MANUFACTURED FOR:



Avion Pharmaceuticals, LLC

Alpharetta, Georgia 30005



1-888-61-AVION

L-0244 Rev. 0325-03

Section 42232-9

PRECAUTIONS:Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.



Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

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

PRENATE PIXIE ®contains fish oil and soy.

OTHER INGREDIENTS: Beeswax, palm shortening and soy lecithin. Capsule (caramel, FD&C blue #1, FD&C red #40, gelatin, glycerin, purified water and titanium dioxide).

Section 51945-4

75854-0316-30

Prenate pixie®

Robust Rx Prenatal Vitamin with

11 concentrated nutrients and minerals

in a tiny softgel package

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Rx Only

Dietary Supplement

30 Softgels


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 PIXIE ®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 softgel daily or as directed by a physician.

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED:Bottles of 30 softgels (75854-0316-30). 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 PIXIE ®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)

Rx Only Dietary Supplement

DESCRIPTION:PRENATE PIXIE ®is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ®contains no ingredient made from gluten-containing grain (wheat, barley, or rye)

Section 42229-5 (42229-5)

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.

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

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.

MANUFACTURED FOR:



Avion Pharmaceuticals, LLC

Alpharetta, Georgia 30005



1-888-61-AVION

L-0244 Rev. 0325-03

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 12is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.



Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

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)

PRENATE PIXIE ®contains fish oil and soy.

OTHER INGREDIENTS: Beeswax, palm shortening and soy lecithin. Capsule (caramel, FD&C blue #1, FD&C red #40, gelatin, glycerin, purified water and titanium dioxide).

Section 51945-4 (51945-4)

75854-0316-30

Prenate pixie®

Robust Rx Prenatal Vitamin with

11 concentrated nutrients and minerals

in a tiny softgel package

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Rx Only

Dietary Supplement

30 Softgels


Advanced Ingredient Data


Raw Label Data

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