Prenate Pixie

Manufacturer
Avion Pharmaceuticals, LLC
Effective date
2025-05-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 21:33:18

Label at a glance#

ProductPrenate Pixie
Active ingredientASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, BLUEBERRY, DOCOSAHEXAENOIC ACID, LEVOMEFOLATE CALCIUM
Label structure12 sections

Boxed warning

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.

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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)

Supplement Facts PanelSupplement Facts Panel

INACTIVE INGREDIENT SECTION

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).

INDICATIONS & USAGE SECTION

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.

CONTRAINDICATIONS SECTION

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

BOXED WARNING SECTION

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.

PRECAUTIONS SECTION

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.

BOXED WARNING SECTION

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.

ADVERSE REACTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

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.

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

bottle labelbottle label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75854-316-30Prenate Pixie30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75854-316PRENATE PIXIE (ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOMEFOLATE CALCIUM, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, DOCOSAHEXAENOIC ACID, AND BLUEBERRY) TABLET, FILM COATED [AVION PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 1 package rows20250515_fe0a737e-4f28-40d8-b4a7-090edf86a823.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-316-30EA - Each75854-3169ee191f3-8870-4d6b-b21d-52a68575fd5912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW86
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R6
BIOTINACTIVE INGREDIENT6SO6U10H046
BLUEBERRYACTIVE INGREDIENT253RUG1X1A6
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF416
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2046
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA06
FERROUS ASPARTO GLYCINATEACTIVE INGREDIENTH7426RGB3L6
FOLIC ACIDACTIVE INGREDIENT935E97BOY86
LEVOMEFOLIC ACIDACTIVE INGREDIENT8S95DH25XC6
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J6
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV6
.ALPHA.-TOCOPHEROL, DL-ACTIVE MOIETY7QWA1RIO016
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R6
BIOTINACTIVE MOIETY6SO6U10H046
BLUEBERRYACTIVE MOIETY253RUG1X1A6
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF416
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2046
DOCUSATEACTIVE MOIETYM7P27195AG6
FERROUS CATIONACTIVE MOIETYGW89581OWR6
FOLIC ACIDACTIVE MOIETY935E97BOY86
IODIDE IONACTIVE MOIETY09G4I6V86Q6
LEVOMEFOLIC ACIDACTIVE MOIETY8S95DH25XC6
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z6
CARAMELINACTIVE INGREDIENTT9D99G2B1R6
CORN OILINACTIVE INGREDIENT8470G57WFM6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA6
GELATININACTIVE INGREDIENT2G86QN327L6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM626
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP6
WATERINACTIVE INGREDIENT059QF0KO0R6
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75854-31675854-316-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii+route
14 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii+route
14 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii+route
14 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
14 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii+route
16 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii+route
16 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii+route
16 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii+route
16 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii+route
16 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii+route
14 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii+route
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii+route
16 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii+route
16 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii+route
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii+route
14 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii+route
14 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii+route
14 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
12 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii+route
14 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii+route
16 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii+route
14 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii+route
16 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
14 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
12 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii+route
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prenate PixieASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOMEFOLATE CALCIUM, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, DOCOSAHEXAENOIC ACID, AND BLUEBERRYAvion Pharmaceuticals, LLCfe0a737e-4f28-40d8-b4a7-090edf86a8232025-05-14Boxed warning, Adverse reactionsExact identifier
ndc (package): 75854-316-30
ndc (product): 75854-316
ndc11 (package): 75854031630
spl id: 3518fe22-c02c-a014-e063-6394a90a4ef1
spl set id: fe0a737e-4f28-40d8-b4a7-090edf86a823

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.