FLU CARE - influenza a virus, influenza b virus, histamine dihydrochloride, aconitum napellus, american ginseng, arsenic trioxide, baptisia tinctoria, 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.

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.

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INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Influenzinum (combo) 30x, Histaminum hydrochloricum 15x, Aconitum nap. 10x, Aralia quinquefolia 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Cinchona 10x, Eupatorium perf. 10x, Gelsemium 10x, Ipecac. 10x, Kali carb. 10x, Nux vom. 10x, Phosphorus 10x, Rhus toxicodendron 10x, Echinacea 3x.

OTC - PURPOSE SECTION

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

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

FLU CARE
influenza a virus, influenza b virus, 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 OTC DRUG	Item Code (Source)	NDC:55714-2208
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Influenza A Virus (Influenza A Virus)	Influenza A Virus	30 [hp_X] in 1 mL
Influenza B Virus (Influenza A Virus)	Influenza B Virus	30 [hp_X] in 1 mL
Histamine Dihydrochloride (Histamine)	Histamine Dihydrochloride	15 [hp_X] in 1 mL
Aconitum Napellus (Aconitum Napellus)	Aconitum Napellus	10 [hp_X] in 1 mL
American Ginseng (American Ginseng)	American Ginseng	10 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	10 [hp_X] in 1 mL
Baptisia Tinctoria (Baptisia Tinctoria)	Baptisia Tinctoria	10 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	10 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	10 [hp_X] in 1 mL
Eupatorium Perfoliatum Flowering Top (Eupatorium Perfoliatum Flowering Top)	Eupatorium Perfoliatum Flowering Top	10 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	10 [hp_X] in 1 mL
Ipecac (Ipecac)	Ipecac	10 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	10 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	10 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	10 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	10 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2208-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2208-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2208-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2208), API MANUFACTURE(55714-2208)

Revised: 03/2011

Document Id: f07401cb-6c6f-c162-d8b6-ad36f946be28

Set id: 17397884-1a9c-32f3-ebcf-fe4b4bf935f4

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.