CAFFEINE WITHDRAWAL - aconitum napellus, silver nitrate, arsenic trioxide, atropa belladonna, benzoic acid, berberis vulgaris root bark, bryonia alba root, lytta vesicatoria, ceanothus americanus leaf, chelidonium majus, chionanthus virginicus bark, cinchona officinalis bark, arabica coffee bean, conium maculatum flowering top, gelsemium sempervirens root, strychnos ignatii seed, iris versicolor root, daphne mezereum bark, strychnos nux-vomica seed, passiflora incarnata flowering top, pulsatilla vulgaris, toxicodendron pubescens leaf, scutellaria lateriflora, delphinium staphisagria seed, matricaria recutita, taraxacum officinale and valerian 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

Caffeine Withdrawal Formulated for symptoms associated with caffeine use such as cravings, headache, irritability, restlessness and fatigue.

DOSAGE & ADMINISTRATION SECTION

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, Arsenicum alb. 15x, Belladonna 15x, Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Coffea cruda 15x, Conium 15x, Gelsemium 15x, Ignatia 15x, Iris versicolor 15x, Mezereum 15x, Nux vom. 15x, Passiflora 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Staphysag. 15x, Chamomilla 3x, Taraxacum 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with caffeine use such as cravings, headache, irritability, restlessness and fatigue.

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

CAFFEINE WITHDRAWAL
aconitum nap., arg. nit., arsenicum alb., belladonna, benzoicum acidum, berber. vulg., bryonia, cantharis, ceanothus, chelidonium majus, chionanthus virginica, cinchona, coffea cruda, conium, gelsemium, ignatia, iris versicolor, mezereum, nux vom., passiflora, pulsatilla, rhus toxicodendron, scutellaria lateriflora, staphysag., chamomilla, taraxacum, valeriana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2278
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
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
Benzoic Acid (Benzoic Acid)	Benzoic Acid	15 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (Berberis Vulgaris Root Bark)	Berberis Vulgaris Root Bark	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria)	Lytta Vesicatoria	15 [hp_X] in 1 mL
Ceanothus Americanus Leaf (Ceanothus Americanus Leaf)	Ceanothus Americanus Leaf	15 [hp_X] in 1 mL
Chelidonium Majus (Chelidonium Majus)	Chelidonium Majus	15 [hp_X] in 1 mL
Chionanthus Virginicus Bark (Chionanthus Virginicus Bark)	Chionanthus Virginicus Bark	15 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Arabica Coffee Bean (Arabica Coffee Bean)	Arabica Coffee Bean	15 [hp_X] in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top)	Conium Maculatum Flowering Top	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed)	Strychnos Ignatii Seed	15 [hp_X] in 1 mL
Iris Versicolor Root (Iris Versicolor Root)	Iris Versicolor Root	15 [hp_X] in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark)	Daphne Mezereum Bark	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Passiflora Incarnata Flowering Top (Passiflora Incarnata Flowering Top)	Passiflora Incarnata Flowering Top	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
Scutellaria Lateriflora (Scutellaria Lateriflora)	Scutellaria Lateriflora	15 [hp_X] in 1 mL
Delphinium Staphisagria Seed (Delphinium Staphisagria Seed)	Delphinium Staphisagria Seed	15 [hp_X] in 1 mL
Matricaria Recutita (Matricaria Recutita)	Matricaria Recutita	3 [hp_X] in 1 mL
Taraxacum Officinale (Taraxacum Officinale)	Taraxacum Officinale	3 [hp_X] in 1 mL
Valerian (Valerian)	Valerian	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2278-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2278-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2278-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/29/2012

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2278), API MANUFACTURE(55714-2278)

Revised: 03/2011

Document Id: 4b185776-fdaa-8df7-7143-d1fd4d1e6ffd

Set id: 5fb9da78-78db-03ea-2a53-7e8d36efc10a

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.