PRENATE AM- .pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated

Prenate AM by

Drug Labeling and Warnings

Prenate AM by is a Prescription medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
With
Quatrefolic ®

Rx Only

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.

• 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

(What is this?)

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.

SPL UNCLASSIFIED SECTION

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.

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.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
Avion Pharmaceuticals, LLC
Atlanta, GA 30350 1-888-61-AVION            Rev. 0513

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

*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

SPL UNCLASSIFIED SECTION

PRENATE ® AM is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

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

INGREDIENTS AND APPEARANCE

PRENATE AM 
.pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	75 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg

Inactive Ingredients
Ingredient Name	Strength
GINGER (UNII: C5529G5JPQ)	500 mg
LINGONBERRY (UNII: 0UNK9RZQ7X)	25 mg
HYPROMELLOSES (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	OVAL	Size	22mm
Flavor		Imprint Code	Prenate;AM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-307-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/15/2013

Labeler - Avion Pharmaceuticals, LLC (965450542)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-307)