HEADACHE - micrurus corallinus venom, arsenic trioxide, atropa belladonna, bryonia alba root, centaurea benedicta, black cohosh, arabica coffee bean, convallaria majalis, crotalus horridus horridus venom, digitalis, gelsemium sempervirens root, nitroglycerin, strychnos ignatii seed, lachesis muta venom, mercury, naja naja venom, strychnos nux-vomica seed, phosphorus, toxicodendron pubescens leaf, sanguinaria canadensis root, claviceps purpurea sclerotium, vipera berus venom, apis mellifera, hypericum perforatum and thuja occidentalis leafy twig 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.

----------

INDICATIONS & USAGE SECTION

Headache Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.

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

Elaps corallinus 30x, Arsenicum alb.15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria 15x, Secale 15x, Vipera berus 15x, Apis mel. 3x, Hypericum 3x, Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.

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

HEADACHE
elaps corallinus, arsenicum alb., belladonna, bryonia, carduus benedictus, cimicifuga, coffea cruda, convallaria, crotalus horridus, digitalis, gelsemium, glonoinum, ignatia, lachesis, merc. viv., naja, nux vom., phosphorus, rhus toxicodendron, sanguinaria, secale, vipera berus, apis mel., hypericum, thuja occ.. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2224
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Micrurus Corallinus Venom (Micrurus Corallinus Venom)	Micrurus Corallinus Venom	30 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Atropa Belladonna (Atropa Belladonna)	Atropa Belladonna	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Centaurea Benedicta (Centaurea Benedicta)	Centaurea Benedicta	15 [hp_X] in 1 mL
Black Cohosh (Black Cohosh)	Black Cohosh	15 [hp_X] in 1 mL
Arabica Coffee Bean (Arabica Coffee Bean)	Arabica Coffee Bean	15 [hp_X] in 1 mL
Convallaria Majalis (Convallaria Majalis)	Convallaria Majalis	15 [hp_X] in 1 mL
Crotalus Horridus Horridus Venom (Crotalus Horridus Horridus Venom)	Crotalus Horridus Horridus Venom	15 [hp_X] in 1 mL
Digitalis (Digitalis)	Digitalis	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Nitroglycerin (Nitroglycerin)	Nitroglycerin	15 [hp_X] in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed)	Strychnos Ignatii Seed	15 [hp_X] in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Mercury (Mercury)	Mercury	15 [hp_X] in 1 mL
Naja Naja Venom (Naja Naja Venom)	Naja Naja Venom	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
Sanguinaria Canadensis Root (Sanguinaria Canadensis Root)	Sanguinaria Canadensis Root	15 [hp_X] in 1 mL
Claviceps Purpurea Sclerotium (Claviceps Purpurea Sclerotium)	Claviceps Purpurea Sclerotium	15 [hp_X] in 1 mL
Vipera Berus Venom (Vipera Berus Venom)	Vipera Berus Venom	15 [hp_X] in 1 mL
Apis Mellifera (Apis Mellifera)	Apis Mellifera	3 [hp_X] in 1 mL
Hypericum Perforatum (Hypericum Perforatum)	Hypericum Perforatum	3 [hp_X] in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig)	Thuja Occidentalis Leafy Twig	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2224-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2224-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2224-0	.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(55714-2224), API MANUFACTURE(55714-2224)

Revised: 03/2011

Document Id: 1764749f-16e5-0650-9705-1f236dc034e9

Set id: 8e5e5377-0458-57d5-3802-de7affcb45cf

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.