ACHES - PAINS - aconitum napellus, silver nitrate, arnica montana, bryonia alba root, colchicum autumnale bulb, guaiac, hypericum perforatum, kalmia latifolia leaf, phosphorus, phytolacca americana root, pulsatilla vulgaris, toxicodendron pubescens leaf, ruta graveolens flowering top, lactic acid, l-, lobaria pulmonaria, datura stramonium, hamamelis virginiana root bark/stem bark and taraxacum officinale 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

Aches - Pains Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

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

Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia latifolia 15x, Phosphorus 15x, Phytolacca 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 15x, Hamamelis 3x, Phytolacca 3x, Ruta 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

INACTIVE INGREDIENT SECTION

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

OTC - 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

ACHES - PAINS
aconitum nap., arg. nit., arnica, bryonia, colchicum, guaiacum, hypericum, kalmia, phosphorus, phytolacca, pulsatilla, rhus toxicodendron, ruta, sarcolacticum ac., sticta, stramonium, hamamelis, taraxacum, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2236
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aconitum Napellus (Aconitum Napellus)	Aconitum Napellus	15 [hp_X] in 1 mL
Silver Nitrate (Silver Cation)	Silver Nitrate	15 [hp_X] in 1 mL
Arnica Montana (Arnica Montana)	Arnica Montana	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Colchicum Autumnale Bulb (Colchicum Autumnale Bulb)	Colchicum Autumnale Bulb	15 [hp_X] in 1 mL
Guaiac (Guaiac)	Guaiac	15 [hp_X] in 1 mL
Hypericum Perforatum (Hypericum Perforatum)	Hypericum Perforatum	15 [hp_X] in 1 mL
Kalmia Latifolia Leaf (Kalmia Latifolia Leaf)	Kalmia Latifolia Leaf	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root)	Phytolacca Americana Root	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Ruta Graveolens Flowering Top (Ruta Graveolens Flowering Top)	Ruta Graveolens Flowering Top	15 [hp_X] in 1 mL
Lactic Acid, L- (Lactic Acid, L-)	Lactic Acid, L-	15 [hp_X] in 1 mL
Lobaria Pulmonaria (Lobaria Pulmonaria)	Lobaria Pulmonaria	15 [hp_X] in 1 mL
Datura Stramonium (Datura Stramonium)	Datura Stramonium	15 [hp_X] in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (Hamamelis Virginiana Root Bark/stem Bark)	Hamamelis Virginiana Root Bark/stem Bark	3 [hp_X] in 1 mL
Taraxacum Officinale (Taraxacum Officinale)	Taraxacum Officinale	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2236-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2236-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2236-0	.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(55714-2236), API MANUFACTURE(55714-2236)

Revised: 03/2011

Document Id: 502dc387-017a-9fcf-e74a-4e147cd852fa

Set id: de933701-e052-286c-2455-e4ee1a6a5a80

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.