PRENATE Enhance
Enhance
cf10de09-6ed5-4a66-84fa-2da4f668bbe6
HUMAN PRESCRIPTION DRUG LABEL
Jan 22, 2024
Avion Pharmaceuticals, LLC
DUNS: 040348516
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 30 Softgel label
75854-309-30
PRENATE**®**Enhance
Rx postnatal vitamin with probiotics and DHA,
1,000 IU Vitamin D and chelated iron
Rx Only
** Dietary Supplement**
30 Softgels
BOXED WARNING SECTION
INDICATIONS & USAGE SECTION
INDICATIONS: PRENATE ® Enhance 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. PRENATE ® Enhance can also be beneficial in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS: PRENATE ® Enhance is contraindicated in patients with a known hypersensitivity to any of the ingredients.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
SPL UNCLASSIFIED SECTION
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Atlanta, GA 30005
1-888-61-AVION
Rev. 0319-01
Formical® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.
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.
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
DESCRIPTION SECTION
DESCRIPTION: PRENATE ® Enhance is a prescription prenatal vitamin that contains 400 mg of DHA and advanced calcium. Each dark purple softgel is imprinted with N on one side and blank on the other.
INACTIVE INGREDIENT SECTION
OTHER INGREDIENTS: Gelatin capsule (FD&C Blue # 1, FD&C Red # 40, gelatin, glycerin, purified water, sorbitol, and titanium dioxide), palm shortening, soy lecithin and white beeswax.
PRECAUTIONS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.
HOW SUPPLIED SECTION
HOW SUPPLIED: Bottles of 30 softgels (75854-309-30). 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.]
WARNINGS SECTION
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.