Prenate Chewable (calcium carbonate 500 mg cholecalciferol 300 [iu] magnesium oxide 50 mg boron 250 ug folic acid 1 mg pyridoxine hydrochloride 10 mg cyanocobalamin 125 mg biotin 280 ug bilberry 25 mg) Dailymed
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A chewable Rx prenatal vitamin with a delicious chocolate flavor
Rx Only
Description Section
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.
Inactive Ingredient Section
OTHER INGREDIENTS: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ®), and Hydrogenated Vegetable Oil (as Sterotex ®).
Indications & Usage Section
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 Section
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 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Adverse Reactions Section
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration Section
DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.
How Supplied Section
HOW SUPPLIED: PRENATE CHEWABLE ® is supplied in child-resistant bottles of 30 tablets (75854-306-30).
The uled 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 Section
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
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
Rev. 0619-05
Recent Major Changes Section
Package Label.principal Display Panel
75854-306-30
Prenate chewable ®
A chewable Rx prenatal vitamin with a delicious chocolate flavor
with Quatrefolic®
Dietary Supplement
30 Tablets
Rx Only
Avion PHARMACEUTICALS
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