Prenate Am
FDA Label NDC 75854-307

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avion Pharmaceuticals, Llc for the product Prenate Am (NDC 75854-307). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, inactive ingredient, boxed warning, dosage & administration, storage and handling, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 Extract500 mg
Lingonberry25 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

Principal Display Panel (30 tablets)

Principal Display Panel (30 tablets)

* Please review the disclaimer below.