NATACHEW- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, niacinamide tablet, chewable

NataChew by

Drug Labeling and Warnings

NataChew by is a Prescription medication manufactured, distributed, or labeled by Eckson Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

• Vitamin A (beta carotene): 2,700 IU
• Vitamin C (sodium ascorbate and ascorbic acid): 120 mg
• Vitamin D 3 (cholecalciferol): 400 IU
• Vitamin E (dl-alpha tocopheryl acetate): 20 IU
• Vitamin B 1 (thiamine mononitrate): 2 mg
• Vitamin B 2 (riboflavin): 3 mg
• Vitamin B 6 (pyridoxine HCl): 10 mg
• Folic Acid: 1 mg
• Vitamin B 12 (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

vM2 Rev. 04/2017 827453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 44118-902
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	2700 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	20 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE MONONITRATE	2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	28 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	13mm
Flavor	CHERRY	Imprint Code	902
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44118-902-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2012
2	NDC: 44118-902-05	9 in 1 CARTON	10/15/2012
2		5 in 1 BOTTLE; Type 0: Not a Combination Product

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)