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NataChew

Generic Name: beta-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron and niacinamide
Dosage Form: tablet, chewable

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

NataChew

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving
Vitamin A (beta carotene) 2,700 IU
Vitamin C (sodium ascorbate and ascorbic acid) 120 mg
Vitamin D3 (cholecalciferol) 400 IU
Vitamin E (d-alpha tocopheryl acetate) 20 IU
Vitamin B1 (thiamine mononitrate) 2 mg
Vitamin B2 (riboflavin) 3 mg
Vitamin B6 (pyridoxine HCl) 10 mg
Folic Acid 1 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Iron (ferrous fumarate and ferrous II bis-glycinate chelate) 28 mg
Niacinamide 20 mg

OTHER 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, LLC
1000 N. West St., Suite 1200, #927
Wilmington, DE 19801
vM1 Rev. 09/2012
NataChew 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, niacinamide tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44118-902
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2700 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 20 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
IRON (IRON) IRON 28 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE  
D&C RED NO. 7  
SUCRALOSE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 400  
STEARIC ACID  
MAGNESIUM STEARATE  
Product Characteristics
Color red Score no score
Shape ROUND Size 13mm
Flavor CHERRY Imprint Code 902
Contains         
Packaging
# Item Code Package Description
1 NDC:44118-902-90 90 TABLET, CHEWABLE (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/15/2012
Labeler - Eckson Labs, LLC (078435242)
Revised: 03/2013
 
Eckson Labs, LLC



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