FDA Label for Prenate Am
View Indications, Usage & Precautions
Prenate Am 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
Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
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.
DISTRIBUTED BY:
Avion Pharmaceuticals, LLC
Atlanta, GA 30350 1-888-61-AVION Rev. 0513
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.
*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 ® AM is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
Description
DESCRIPTION: PRENATE ® AM is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "Prenate" on one side and "AM" on the other.
| Supplement Facts Serving Size: 1 Tablet | |
| Each Tablet Contains: | |
| Vitamin B6 (Pyridoxine Hydrochloride) | 75 mg |
| Vitamin B12 (Cyanocobalamin) | 12 mcg |
| Calcium (as Calcium Carbonate) | 200 mg |
| 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 |
| Ginger Extract | 500 mg |
| Lingonberry | 25 mg |
Inactive Ingredient
OTHER INGREDIENTS: Methocel K, stearic acid, magnesium stearate and silicon dioxide, dicalcium phosphate
Boxed Warning
PRECAUTIONS: Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding. 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. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and any drugs, herbs and/or supplements consumption should be considered.
Dosage & Administration
DOSAGE AND ADMINISTRATION: One tablet daily or as directed by your doctor.
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.]
Warnings
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Package Label.Principal Display Panel
75854-307-30
Prenate
® Am
Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
With
Quatrefolic
®
PRENATE® AM’s formulation eases symptoms
commonly associated with pregnancy, including
nausea and vomiting.
30 Tablets
Rx Only
Avion
PHARMACEUTICALS
* Please review the disclaimer below.