Novadha Baby Dha (Omega-3 Fatty Acids, Cholecalciferol, And .alpha.-Tocopherol) Liquid [Gensavis Pharmaceuticals, Llc] -

NOVADHA BABY DHA (OMEGA-3 FATTY ACIDS, CHOLECALCIFEROL, AND .ALPHA.-TOCOPHEROL) LIQUID [GENSAVIS PHARMACEUTICALS, LLC]
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NDC	52304-719-50
Set ID	54d9bd6d-0d59-45af-957d-cbebd22f0918
Category	DIETARY SUPPLEMENT
Packager	Gensavis Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number

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STATEMENT OF IDENTITY

Supplement Facts SERVING SIZE 5 ml* SERVINGS PER BOTTLE: 12
Amount Per Serving	% Daily Value
* Infants under 1 year of age.
* Refer to back of box for suggested use. † Daily Value not established
Calories	45
Total Fat	5.0 g	†
Vitamin A	230-902 IU	15-61%
Vitamin D-3	400 IU	100%
Total Omega-3s	1050 mg	†
EPA (Eicosapentaenoic Acid)	350 mg	†
DHA (Docosahexaenoic Acid)	485 mg	†
Other Omega-3s	215 mg	†

OTHER INGREDIENTS: Purified arctic cod liver oil, rosemary extract (a natural preservative), D-alpha tocopherol, cholecalciferol in medium chain triglycerides.

No gluten, milk derivative or artificial colors or flavors

WARNING

Consult with your physician before using this product if your child is allergic to iodine, using blood thinners, or anticipates surgery.
SAFE HANDLING WARNING

Do not use if seal is broken or missing.
SUGGESTED USE

Shake well before use.

As a dietary supplement for infants and children ranging from 5 to 35 pounds in weight. Take as directed unless otherwise instructed by your child's physician.
HEALTH CLAIM

Distributed by:
Gensavis®
PHARMACEUTICALS LLC

Gensavis Pharmaceuticals, LLC
Corpus Christi, TX 78415

Manufactured in the USA

Questions or Comments?
Call 972-836-7783
Monday–Friday, 9:00am to 4:30pm EST
Or visit our website at
www.novaferrum.com
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

NovaDHA™
PEDIATRIC DROPS
DIETARY SUPPLEMENT

omega-3
supplement

For Infants & Children
Under 4 Years of Age

2 FL OZ (60 mL)

INGREDIENTS AND APPEARANCE

NOVADHA BABY DHA
omega-3 fatty acids, cholecalciferol, and .alpha.-tocopherol liquid

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:52304-719
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S)	Omega-3 Fatty Acids	1050 mg in 5 mL
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU] in 5 mL
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1)	.Alpha.-Tocopherol	6 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Rosemary (UNII: IJ67X351P9)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:52304-719-50	60 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
DIETARY SUPPLEMENT		02/01/2016

Labeler - Gensavis Pharmaceuticals, LLC (961905879)

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Medic

NOVADHA BABY DHA (OMEGA-3 FATTY ACIDS, CHOLECALCIFEROL, AND .ALPHA.-TOCOPHEROL) LIQUID [GENSAVIS PHARMACEUTICALS, LLC]

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