Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Dosage Form: capsule, gelatin coated
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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Rx postnatal vitamin with probiotics and DHA
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.
Serving Size: 1 Softgel
|Amount per Serving:||% Daily
|Vitamin C (as Ascorbic Acid)||85 mg||142%||142%|
(as Dl-Alpha Tocopherol)
(as 1.1mg Quatrefolic ® ((6S)-5, Methyltetrahydrofolate Glucosamine Salt* CAS 1181972-37-1) molar equivalent to 600mcg of Folic Acid) (Folic Acid, USP 400mcg)
|Vitamin B6 (as Pyridoxine HCl)||25 mg||1000%||1000%|
|Calcium (blend of Formical ®
and Calcium Carbonate)
|Iron (as Ferrous Fumarate)||27 mg||150%||150%|
(as Magnesium Oxide)
(as Lactospore ®)
150 Million CFU
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.
Avion Pharmaceuticals, LLC
Atlanta, GA 30350
*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.
PRINCIPAL DISPLAY PANEL - 30 Softgel label
PRENATE ® Restore
Rx postnatal vitamin with probiotics and DHA
with Quatrefolic ®
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent capsule, gelatin coated
|Labeler - Avion Pharmaceuticals, LLC (965450542)|
|Avion Pharmaceuticals, LLC||965450542||manufacture(75854-308)|
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