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Prenate AM Prescribing Information

Package insert / product label
Generic name: pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid
Dosage form: tablet, coated

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
With

Quatrefolic ®

Rx Only

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.

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

OTHER INGREDIENTS: Methocel K, stearic acid, magnesium stearate and silicon dioxide, dicalcium phosphate

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by your doctor.

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.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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.

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
PRENATE AM
.pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE75 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScore2 pieces
ShapeOVALSize22mm
FlavorImprint CodePrenate;AM
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75854-307-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2013
Labeler - Avion Pharmaceuticals, LLC (965450542)
Establishment
NameAddressID/FEIBusiness Operations
Avion Pharmaceuticals, LLC040348516manufacture(75854-307)