PRENATE Restore | PRENATE Restore [Avion Pharmaceuticals, LLC] | BioPortfolio

Rx postnatal vitamin with probiotics and DHA

With Quatrefolic

Rx Only Dietary Supplement

DESCRIPTION: PRENATE Restore is a prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other.

OTHER INGREDIENTS: Bovine Gelatin, Glycerin, Soy Lecithin, White Beeswax, Vegetable Shortening, Purified Water, FD&C Blue #1, Titanium Dioxide and FD&C Red #3.

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.

INDICATIONS: PRENATE Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and non-lactating mothers.

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

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: 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.

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

DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.

HOW SUPPLIED: Bottles of 30 softgels (75854-308-30). 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: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

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

MANUFACTURED FOR: Avion Pharmaceuticals, LLC Atlanta, GA 30350 1-888-61-AVION

*Quatrefolic is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

Formical is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542

PRENATE is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

Rev. 0913

75854-308-30

PRENATE Restore Rx postnatal vitamin with probiotics and DHA with Quatrefolic

Rx Only Dietary Supplement 30 Softgels

Avion PHARMACEUTICALS

Manufacturer

Avion Pharmaceuticals, LLC

Active Ingredients

Source

• U.S. National Library of Medicine
• DailyMed
• Last Updated: 27 Jan 2019