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  5. Label Information: Prenate Restore

FDA Label for Prenate Restore

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION
    3. INACTIVE INGREDIENT
    4. INDICATIONS & USAGE
    5. CONTRAINDICATIONS
    6. BOXED WARNING
    7. PRECAUTIONS
    8. ADVERSE REACTIONS
    9. DOSAGE & ADMINISTRATION
    10. HOW SUPPLIED
    11. STORAGE AND HANDLING
    12. WARNINGS
    13. PRINCIPAL DISPLAY PANEL - 30 SOFTGEL LABEL

Prenate Restore Product Label

The following document was submitted to the FDA by the labeler of this product Avion Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Rx postnatal vitamin with probiotics and DHA

With
Quatrefolic ®

Rx Only Dietary Supplement

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.

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


Description



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.

Supplement Facts
Serving Size: 1 Softgel
Amount per Serving:% Daily
Value
(Pregnant
Women) 		% Daily
Value
(Lactating
Women)
Vitamin C (as Ascorbic Acid)85 mg142%142%
Vitamin D3
(as Cholecalciferol) 		1000 IU250%250%
Vitamin E
(as Dl-Alpha Tocopherol) 		10 IU33%33%
Folate
(as 1.1mg Quatrefolic ® ((6S)-5, Methyltetrahydrofolate Glucosamine Salt* CAS 1181972-37-1) molar equivalent to 600mcg of Folic Acid) (Folic Acid, USP 400mcg) 		1 mg250%125%
Vitamin B6 (as Pyridoxine HCl)25 mg1000%1000%
Vitamin B12
(as Cyanocobalamin) 		12 mcg200%150%
Biotin500 mg167%167%
Calcium (blend of Formical ®
and Calcium Carbonate) 		155 mg16%12%
Iron (as Ferrous Fumarate)27 mg150%150%
Magnesium
(as Magnesium Oxide) 		45 mg11%10%
Bacillus Coagulans
(as Lactospore ®)
150 Million CFU 		10 mg

Daily Value (DV) not established.

Docosahexaenoic Acid
(DHA) 		400 mg

Inactive Ingredient



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


Indications & Usage



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



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


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


How Supplied



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 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.]


Warnings



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


Principal Display Panel - 30 Softgel Label



75854-308-30

PRENATE ® Restore
Rx postnatal vitamin with probiotics and DHA
with Quatrefolic ®

Rx Only
Dietary Supplement
30 Softgels

Avion
PHARMACEUTICALS


* Please review the disclaimer below.