Prenate Chewable Tablet, Chewable
FDA Label NDC 75854-306

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 Chewable (NDC 75854-306). 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, indications & usage, contraindications, precautions, adverse reactions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

A chewable Rx prenatal vitamin with a delicious chocolate flavor
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.

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

PRENATE CHEWABLE ™ is a trademark of Avion Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

Rev. 0113

Description

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.

Supplement Facts
Serving Size: 1 Tablet
Amount per Serving:% Daily Value
Calcium (as calcium carbonate)500 mg
Vitamin D3300 IU
Magnesium (as magnesium oxide)50 mg
Boron Amino Acid Chelate250 mcg
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
Vitamin B6 (as pyridoxine HCL)10 mg
Vitamin B12 (as Cyanocobalamin)125 mcg
Biotin280 mcg
Blueberry Extract25 mg

Inactive Ingredient

OTHER INGREDIENTS: Natural Dutch Chocolate, Fructose, Gum Acacia, Magnesium Stearate, Silicon Dioxide, Chocolate Flavor

Indications & Usage

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

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

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Dosage & Administration

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

How Supplied

HOW SUPPLIED: PRENATE CHEWABLE ™ is supplied in child-resistant bottles of 30 tablets (75854-306-30).

The listed 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

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

Package Label.Principal Display Panel

75854-306-30

Prenate chewable ™

A chewable Rx prenatal vitamin with a delicious chocolate flavor

with
Quatrefolic ®

30 Tablets

Rx Only

Avion
PHARMACEUTICALS

* Please review the disclaimer below.