Label: PRENATE PIXIE- ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated
- NDC Code(s): 75854-316-30
- Packager: Avion Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated January 5, 2018
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- BOXED WARNING(What is this?)
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.
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.Close
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”.
Serving Size: 1 Softgel
Amount per Serving: % Daily
Vitamin C (as ascorbic acid) 30 mg 50% 50% Biotin 75 mcg 25% 25% Vitamin D3
500 IU 125% 125% Vitamin B12
13 mcg 217% 163% Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg) 1 mg 250% 125% Iron (as ferrous asparto glycinate) Sumalate ® 10 mg 56% 56% Iodine (as potassium iodide) 150 mcg 100% 100% Vitamin B6 (as pyridoxine HCl) 5 mg 250% 200% Vitamin E
(as dl-alpha tocopheryl acetate)
10 IU 33% 33% Docosahexaenoic acid (DHA) 200 mg † † Blueberry extract
5 mg † †
† Daily Value (DV) not established.
PRENATE ® PIXIE contains fish oil and soy.Close
- INACTIVE INGREDIENT
OTHER INGREDIENTS: Bovine gelatin, glycerin, yellow beeswax, soy lecithin, vegetable shortening, purified water, titanium dioxide, FD&C Red #40, caramel and FD&C Blue #1.Close
- 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.Close
CONTRAINDICATIONS: PRENATE ® PIXIE is contraindicated in patients with a known hypersensitivity to any of the ingredients.Close
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.Close
- ADVERSE REACTIONS
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Close
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.Close
- 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.Close
- 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.]Close
- SPL UNCLASSIFIED SECTION
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.
PRENATE ®Pixie is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 softgel container image
Robust Rx Prenatal Vitamin with
11 concentrated nutrients and minerals
in a tiny softgel package
R x Only
- INGREDIENTS AND APPEARANCE
ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-316 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 30 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 75 ug CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 500 [iU] CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 13 ug FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 400 ug FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 10 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 150 ug PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 5 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 10 [iU] DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 200 mg BLUEBERRY (UNII: 253RUG1X1A) (BLUEBERRY - UNII:253RUG1X1A) BLUEBERRY 5 mg LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 600 ug Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) YELLOW WAX (UNII: 2ZA36H0S2V) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CORN OIL (UNII: 8470G57WFM) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) CARAMEL (UNII: T9D99G2B1R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color purple Score no score Shape OVAL Size 22mm Flavor Imprint Code PIX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75854-316-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/14/2014 Labeler - Avion Pharmaceuticals, LLC (965450542) Establishment Name Address ID/FEI Business Operations Avion Pharmaceuticals, LLC 965450542 manufacture(75854-316)