INFLUENZA - influenza a virus, influenza b virus, histamine dihydrochloride, aconitum napellus, american ginseng, arsenic trioxide, baptisia tinctoria root, bryonia alba root, cinchona officinalis bark, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, potassium carbonate, strychnos nux-vomica seed, phosphorus, toxicodendron pubescens leaf and echinacea, unspecified liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Influenza

PRODUCT NAME & INDICATIONS SECTION

Influenza Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, respiratory dysfunction and digestive upset.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Influenzinum (combo) 35x, Histaminum hydrochloricum 20x, Aconitum nap. 15x, Aralia quinquefolia 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Eupatorium perf. 15x, Gelsemium 15x, Ipecac. 15x, Kali carb. 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Echinacea 8x, Echinacea 3x.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper- evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

INFLUENZA
influenzinum (combo), histaminum hydrochloricum, aconitum nap., aralia quinquefolia, arsenicum alb., baptisia, bryonia, cinchona, eupatorium perf., gelsemium, ipecac., kali carb., nux vom., phosphorus, rhus toxicodendron, echinacea liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4410
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Influenza A Virus (Influenza A Virus)	Influenza A Virus	35 [hp_X] in 1 mL
Influenza B Virus (Influenza B Virus)	Influenza B Virus	35 [hp_X] in 1 mL
Histamine Dihydrochloride (Histamine)	Histamine Dihydrochloride	20 [hp_X] in 1 mL
Aconitum Napellus (Aconitum Napellus)	Aconitum Napellus	15 [hp_X] in 1 mL
American Ginseng (American Ginseng)	American Ginseng	15 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Baptisia Tinctoria Root (Baptisia Tinctoria Root)	Baptisia Tinctoria Root	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Eupatorium Perfoliatum Flowering Top (Eupatorium Perfoliatum Flowering Top)	Eupatorium Perfoliatum Flowering Top	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Ipecac (Ipecac)	Ipecac	15 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	8 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4410-1	29.57 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4410), API MANUFACTURE(55714-4410)

Revised: 6/2011

Document Id: 9e4d9759-843a-5008-2403-f603202773eb

Set id: 1fc2ebaa-baf6-89a2-6941-cc98df4dad6e

Version: 1

Effective Time: 20110601

Newton Laboratories, Inc.