Prenate Elite Tablet, Coated
FDA Label NDC 75854-314

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 Elite (NDC 75854-314). 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, boxed warning, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Rx Only Dietary Supplement

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.

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

Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

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

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION

Rev. 0614

Description

DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other.

Supplement Facts
Serving Size: 1 Tablet
Amount per Serving:% Daily Value% Daily Value
(Pregnant
& Lactating
Women
Vitamin A (100% as beta-carotene)2600 IU52%33%
Vitamin C (as ascorbic acid)75 mg125%125%
Vitamin D 3 (as cholecalciferol) 600 IU150%150%
Vitamin E (as dl-alpha tocopheryl acetate)40 IU133%133%
Thiamin (as thiamine mononitrate)3 mg200%176%
Riboflavin3.5 mg206%175%
Niacinamide21 mg105%105%
Vitamin B 6 (as pyridoxine HCl) 21 mg1050%840%
Folate
(as 1.11 mg of ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg) 		1 mg250%125%
Calcium (as calcium formate) Formical ®155 mg16%12%
Iron (as ferrous asparto glycinate) Sumalate ®20 mg111%111%
Vitamin B 12 (as cyanocobalamin) 13 mcg217%163%
Biotin330 mcg110%110%
Iodine (as potassium iodide)150 mcg100%100%
Magnesium (as magnesium oxide)25 mg6%6%
Zinc (as zinc oxide)15 mg100%100%
Copper (as cupric oxide)1.5 mg75%75%

Inactive Ingredient

OTHER INGREDIENTS: Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydro Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).

Indications & Usage

INDICATIONS: PRENATE ELITE ® is a multivitamin/multimineral fatty acid 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.

Contraindications

CONTRAINDICATIONS: PRENATE ELITE ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Boxed Warning

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Adverse Reactions

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

Dosage & Administration

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

How Supplied

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). 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.

Storage And Handling

STORAGE: 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

75854-314-30

Prenate Elite ®
PRENATAL VITAMINS-FILM-COATED TABLETS

GLUTEN FREE
Rx Only
Dietary Supplement

30 Tablets

AVION
PHARMACEUTICALS

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