NDC 75854-313 Prenate Essential

Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, 5-methyltetrahydrofolic Acid, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent

NDC Product Code 75854-313

NDC CODE: 75854-313

Proprietary Name: Prenate Essential What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, 5-methyltetrahydrofolic Acid, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Drug uses not available
  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.
  • Drug uses not available
  • Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant. Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced. In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).
  • This medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Magnesium is very important for the normal functioning of cells, nerves, muscles, bones, and the heart. Usually, a well-balanced diet provides normal blood levels of magnesium. However, certain situations cause your body to lose magnesium faster than you can replace it from your diet. These situations include treatment with water pills (diuretics such as furosemide, hydrochlorothiazide), a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).

Product Characteristics

Color(s):
GREEN (C48329)
YELLOW (C48330 - OPAQUE)
Shape: OVAL (C48345)
Size(s):
24 MM
Imprint(s):
PRENATE
Score: 1

NDC Code Structure

  • 75854 - Avion Pharmaceuticals, Llc

NDC 75854-313-30

Package Description: 30 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC Product Information

Prenate Essential with NDC 75854-313 is a a human prescription drug product labeled by Avion Pharmaceuticals, Llc. The generic name of Prenate Essential is ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Avion Pharmaceuticals, Llc

Dosage Form: Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prenate Essential Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ICOSAPENT 40 mg/1
  • ASCORBIC ACID 90 mg/1
  • CHOLECALCIFEROL 220 [iU]/1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 10 [iU]/1
  • PYRIDOXINE HYDROCHLORIDE 26 mg/1
  • FOLIC ACID 400 ug/1
  • 5-METHYLTETRAHYDROFOLIC ACID 600 ug/1
  • CYANOCOBALAMIN 13 ug/1
  • BIOTIN 280 ug/1
  • CALCIUM FORMATE 155 mg/1
  • FERROUS ASPARTO GLYCINATE 18 mg/1
  • POTASSIUM IODIDE 150 ug/1
  • MAGNESIUM OXIDE 50 mg/1
  • DOCONEXENT 300 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • WATER (UNII: 059QF0KO0R)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avion Pharmaceuticals, Llc
Labeler Code: 75854
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-18-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prenate Essential Product Label Images

Prenate Essential Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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 ESSENTIAL


® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with 'Prenate' on one side and blank on the other.


Supplement Facts



Serving Size: 1 Softgel


Amount per Serving:% Daily Value% Daily


Value


(Pregnant &


Lactating


Women)


Vitamin C (as ascorbic acid)90 mg150%150%Vitamin D


3 (as cholecalciferol)


220 IU55%55%Vitamin E (as dl-alpha tocopheryl acetate)10 IU33%33%Vitamin B


6 (as pyridoxine HCl)


26 mg1300%1040%Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt
(molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg)1 mg250%125%Vitamin B


12 (as cyanocobalamin)


13 mcg217%163%Biotin280 mcg93%93%Calcium (as calcium formate)
Formical


®155 mg16%12%Iron (as ferrous asparto glycinate) Sumalate


®18 mg100%100%Iodine (as potassium iodine)150 mcg100%100%Magnesium (as magnesium oxide)50 mg13%11%Docosahexaenoic acid (DHA)300 mgDaily Value (DV) not established.Eicosapentaenoic acid (EPA)40 mg PRENATE ESSENTIAL


® contains fish oil and soy.

Inactive Ingredient

OTHER INGREDIENTS: Bovine gelatin, glycerin, soy lecithin, white beeswax, purified water, soybean oil, titanium dioxide, FD&C yellow #5, FD&C Blue #1, and FD&C yellow #6.

Indications & Usage

INDICATIONS: PRENATE ESSENTIAL


® 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 ESSENTIAL


® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Boxed Warning

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR).
Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

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.

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.

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 softgel daily or as directed by a physician.

How Supplied

HOW SUPPLIED: Bottles of 30 softgels (75854-313-30). 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.]

* Please review the disclaimer below.