FDA Label for Prenate Chewable
View Indications, Usage & Precautions
Prenate Chewable 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
A chewable Rx prenatal vitamin with a delicious chocolate flavor
With
Quatrefolic
®
Rx Only
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
PRENATE CHEWABLE ™ is a trademark of Avion Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
Rev. 0113
Description
DESCRIPTION: PRENATE CHEWABLE ™ is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other.
Supplement Facts
Serving Size: 1 Tablet | |
Amount per Serving: | % Daily Value |
Calcium (as calcium carbonate) | 500 mg |
Vitamin D3 | 300 IU |
Magnesium (as magnesium oxide) | 50 mg |
Boron Amino Acid Chelate | 250 mcg |
Folate
(as 1.1 mg Quatrefolic® ((6S)-5,-methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) | 1 mg |
Vitamin B6 (as pyridoxine HCL) | 10 mg |
Vitamin B12 (as Cyanocobalamin) | 125 mcg |
Biotin | 280 mcg |
Blueberry Extract | 25 mg |
Inactive Ingredient
OTHER INGREDIENTS: Natural Dutch Chocolate, Fructose, Gum Acacia, Magnesium Stearate, Silicon Dioxide, Chocolate Flavor
Indications & Usage
INDICATIONS: PRENATE CHEWABLE ™ is a multivitamin/multimineral 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 CHEWABLE ™ can also be beneficial in improving the nutritional status of women prior to conception.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Precautions
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 0.1 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 tablet daily or as directed by a physician.
How Supplied
HOW SUPPLIED: PRENATE CHEWABLE ™ is supplied in child-resistant bottles of 30 tablets (75854-306-30).
The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
Storage And Handling
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Package Label.Principal Display Panel
75854-306-30
Prenate chewable ™
A chewable Rx prenatal vitamin with a delicious chocolate flavor
with
Quatrefolic
®
30 Tablets
Rx Only
Avion
PHARMACEUTICALS
* Please review the disclaimer below.