NOVAFERRUM MULTIVITAMIN WITH IRON PEDIATRIC DROPS- iron, vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine, rib

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7), Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T), Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R), Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP, Cholecalciferol - UNII:1C6V77QF41), .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1), Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J), Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR), Niacin (UNII: 2679MF687A) (Niacin - U
Available from:
Gensavis Pharmaceuticals, LLC
Administration route:
ORAL
Therapeutic indications:
Shake well before use. As a dietary supplement for infants and children under 4 years of age: 1 mL dropper daily unless otherwise directed by physician.
Authorization status:
Dietary Supplement
Authorization number:
52304-716-50

NOVAFERRUM MULTIVITAMIN WITH IRON PEDIATRIC DROPS- iron, vitamin a,

ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine, riboflavin, niacin, and pyridoxine liquid

Gensavis Pharmaceuticals, LLC

----------

NovaFerrum

PEDIATRIC DROPS

DIETARY SUPPLEMENT

Supplement Facts

Serving Size: 1 mL

Servings Per Container: 50

Amount Per Serving

% Daily Value

Infants

Under 12

Months

Children

Under 4

Years

Vitamin A 1500 IU

100%

Vitamin C 35 mg

100%

Vitamin D 400 IU

100%

100%

Vitamin E 5 IU

100%

Thiamin 0.5 mg

100%

Riboflavin 0.6 mg

100%

Niacin 8 mg

100%

Vitamin B6 0.4 mg

100%

Iron 10 mg

100%

OTHER INGREDIENTS: Natural Vegetable Glycerin, Water, Organic Rice Bran Extract, Natural

Flavor, Citric Acid, Xanthan Gum, Natural Color, Lo Han (Monk Fruit) Extract, Sorbic Acid, Benzoic

Acid, Talin (Thaumatin From Katemfe Fruit)

SUGGESTED USE

Shake well before use.

As a dietary supplement for infants and children under 4 years of age: 1 mL dropper daily unless

otherwise directed by physician.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal

poisoning in children under 6. Keep this product our of reach of children. In case of

accidental overdose, call a doctor or poison control center immediately.

Do not use if seal is broken or missing.

Distributed by:

Gensavis Pharmaceuticals, LLC

Corpus Christi, TX 78415

Call 972-836-7783

www.novaferrum.com

MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

®

NovaFerrum

PEDIATRIC DROPS

DIETARY SUPPLEMENT

multivitamin

WITH IRON

KOSHER

Great

tasting!

Ras pberry

Grape Flavor

For Infants & Children

Under 4 Years of Age

1 FL OZ (50mL)

NOVAFERRUM MULTIVITAMIN WITH IRON PEDIATRIC DROPS

iron, vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine, riboflavin, niacin, and pyridoxine liquid

Product Information

Product T ype

DIETARY SUPPLEMENT

Ite m Code (Source )

NHRIC:5230 4-716

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

Iro n (UNII: E1UOL152H7) (Iro n - UNII:E1UOL152H7)

Iro n

10 mg in 1 mL

Vita min A (UNII: 8 1G40 H8 B0 T) (Vitamin A - UNII:8 1G40 H8 B0 T)

Vitamin A

150 0 [iU]

in 1 mL

®

Serving Size :

Serving per Container :

Gensavis Pharmaceuticals, LLC

in 1 mL

Asco rbic Acid (UNII: PQ6 CK8 PD0 R) (Asco rbic Acid - UNII:PQ6 CK8 PD0 R)

Asco rbic Acid

35 mg in 1 mL

Vita min D (UNII: 9 VU1KI44GP) (Vitamin D - UNII:9 VU1KI44GP, Cho lecalcifero l -

UNII:1C6 V77QF41)

Vitamin D

40 0 [iU] in 1 mL

.Alpha .-To co phero l (UNII: H4N8 55PNZ1) (.Alpha.-To co phero l - UNII:H4N8 55PNZ1)

.Alpha .-To c o phe ro l

5 [iU] in 1 mL

Thia mine (UNII: X6 6 NSO3N35) (Thiamine Io n - UNII:4ABT0 J9 45J)

Thia mine

0 .5 mg in 1 mL

Ribo fla vin (UNII: TLM29 76 OFR) (Ribo flavin - UNII:TLM29 76 OFR)

Ribo fla vin

0 .6 mg in 1 mL

Nia cin (UNII: 26 79 MF6 8 7A) (Niacin - UNII:26 79 MF6 8 7A)

Nia c in

8 mg in 1 mL

Pyrido xine (UNII: KV2JZ1BI6 Z) (Pyrido xine - UNII:KV2JZ1BI6 Z)

Pyrido xine

0 .4 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

Xa ntha n Gum (UNII: TTV12P4NEE)

Sira itia Gro sveno rii Fruit (UNII: NOU2FB51TW)

So rbic Acid (UNII: X0 45WJ9 8 9 B)

Benzo ic Acid (UNII: 8 SKN0 B0 MIM)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:5230 4-716 -50

50 mL in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

DIETARY SUPPLEMENT

0 1/0 1/20 15

Supplement Facts

Amount Per Serving

% Daily Value

color

flavor

flavor

Labeler -

Gensavis Pharmaceuticals, LLC (961905879)

Revised: 8/2019

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