NDC 44118-902 Natachew

.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron, Niacinamide

NDC Product Code 44118-902

NDC CODE: 44118-902

Proprietary Name: Natachew 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: .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron, Niacinamide 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.
  • This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.
  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.

Product Characteristics

Color(s):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
902
Score: 1
Flavor(s):
CHERRY (C73375)

NDC Code Structure

NDC 44118-902-05

Package Description: 9 BOTTLE in 1 CARTON > 5 TABLET, CHEWABLE in 1 BOTTLE

NDC 44118-902-90

Package Description: 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Natachew with NDC 44118-902 is a a human prescription drug product labeled by Eckson Labs, Llc. The generic name of Natachew is .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, niacinamide. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Eckson Labs, Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Natachew 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.

  • .BETA.-CAROTENE 2700 [iU]/1
  • ASCORBIC ACID 120 mg/1
  • CHOLECALCIFEROL 400 [iU]/1
  • .ALPHA.-TOCOPHEROL ACETATE, D- 20 [iU]/1
  • THIAMINE MONONITRATE 2 mg/1
  • RIBOFLAVIN 3 mg/1
  • PYRIDOXINE HYDROCHLORIDE 10 mg/1
  • FOLIC ACID 1 mg/1
  • CYANOCOBALAMIN 12 ug/1
  • IRON 28 mg/1
  • NIACINAMIDE 20 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.

  • SUCROSE (UNII: C151H8M554)
  • D&C RED NO. 7 (UNII: ECW0LZ41X8)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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.
  • 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)

Product Labeler Information

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

Labeler Name: Eckson Labs, Llc
Labeler Code: 44118
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: 10-15-2012 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: 12-31-2020 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.

Natachew Product Label Images

Natachew 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

Description

Supplement Facts

Serving Size: 1 Tablet
Amount Per ServingVitamin A (beta carotene)2,700 IUVitamin C (sodium ascorbate and ascorbic acid)120 mgVitamin D
3 (cholecalciferol)
400 IUVitamin E (dl-alpha tocopheryl acetate)20 IUVitamin B
1 (thiamine mononitrate)
2 mgVitamin B
2 (riboflavin)
3 mgVitamin B
6 (pyridoxine HCl)
10 mgFolic Acid1 mgVitamin B
12 (cyanocobalamin)
12 mcgIron (ferrous fumarate and ferrous II bis-glycinate chelate)28 mgNiacinamide20 mgOTHER INGREDIENTS: sugar, D&C red #7 calcium lake, sucralose, flavor, microcrystalline cellulose, polyethylene glycol 400, stearic acid, magnesium stearate

Indications And Usage:

NataChew
® is a prescription pre/post-natal multivitamin, multimineral indicated for use in improving the nutritional status of women throughout pregnancy, as well as in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status of women prior to conception.

Contraindications:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Warnings And Precautions:

Folic acid is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs, and/or supplements should be considered.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.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

Dosage And Administration:

One tablet daily with or without food or as prescribed by a physician.

How Supplied:

NataChew
® is supplied as a red tablet, imprinted “902”, in child-resistant bottles of 90 tablets, NDC 44118-902-90.
Store between 15°C and 30°C (between 59°F and 86°F). Tamper evident by foil seal under cap.Manufactured for:Eckson Labs, LLC1000 N. West St., Suite 1200, #927

Wilmington, DE 19801

vM2 Rev. 04/2017 827453

* Please review the disclaimer below.