Description
Rx Only
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”.
Supplement Facts (Supplement Facts)
Prenate Pixie Tablet, Film Coated
FDA Label NDC 75854-316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avion Pharmaceuticals, Llc for the product Prenate Pixie (NDC 75854-316). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, inactive ingredient, indications & usage, boxed warning, precautions, adverse reactions, dosage & administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
OTHER INGREDIENTS: Capsule gelatin (gelatin, glycerin, purified water, titanium dioxide, FD&C red #40, caramel, and FD&C blue #1), palm shortening, soy lecithin, and yellow beeswax. PRENATE PIXIE® contains fish oil and soy.
Indications & 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.
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.
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.
Precautions
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.
Adverse Reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
How Supplied
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
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Other
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
Rev. 0519-03
Contraindications
CONTRAINDICATIONS: PRENATE PIXIE® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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
* Please review the disclaimer below.
