APPETITE CRAVING CONTROL - semecarpus anacardium juice, antimony trisulfide, silver nitrate, berberis vulgaris root bark, bryonia alba root, chelidonium majus, digitalis, graphite, hops, iris versicolor root, potassium carbonate, lycopodium clavatum spore, sodium carbonate, sodium sulfate, strychnos nux-vomica seed, pulsatilla vulgaris, toxicodendron pubescens leaf, scutellaria lateriflora, sepia officinalis juice, datura stramonium, matricaria recutita, passiflora incarnata flowering top 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

Appetite Craving Control Formulated for symptoms associated with appetite control such as overeating, cravings, fatigue and emotional discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 6 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

Anacardium orientale 15x, Antimon.crud. 15x, Arg. nit. 15x, Berber. vulg. 15x, Bryonia 15x,Chelidonium majus 15x, Digitalis 15x, Graphites 15x, Humulus 15x,Iris versicolor 15x, Kali carb. 15x, Lycopodium 15x, Nat. carb. 15x,Nat. sulphuricum 15x, Nux vom. 15x, Pulsatilla 15x, Rhustoxicodendron 15x, Scutellaria lateriflora 15x, Sepia 15x,Stramonium 15x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with appetite control such as overeating, cravings, fatigue and emotional discomfort.

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, GA30012
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

APPETITE CRAVING CONTROL
anacardium orientale, antimon.crud., arg. nit., berber. vulg., bryonia, chelidonium majus, digitalis, graphites, humulus,iris versicolor, kali carb., lycopodium, nat. carb.,nat. sulphuricum, nux vom., pulsatilla, rhus. toxicodendron, scutellaria lateriflora, sepia,stramonium, chamomilla, passiflora, valeriana. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2252
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Semecarpus Anacardium Juice (Semecarpus Anacardium Juice)	Semecarpus Anacardium Juice	15 [hp_X] in 1 mL
Antimony Trisulfide (Antimony)	Antimony Trisulfide	15 [hp_X] in 1 mL
Silver Nitrate (Silver Cation)	Silver Nitrate	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
Chelidonium Majus (Chelidonium Majus)	Chelidonium Majus	15 [hp_X] in 1 mL
Digitalis (Digitalis)	Digitalis	15 [hp_X] in 1 mL
Graphite (Graphite)	Graphite	15 [hp_X] in 1 mL
Hops (Hops)	Hops	15 [hp_X] in 1 mL
Iris Versicolor Root (Iris Versicolor Root)	Iris Versicolor Root	15 [hp_X] in 1 mL
Potassium Carbonate (Potassium Cation)	Potassium Carbonate	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Sodium Carbonate (Sodium Cation)	Sodium Carbonate	15 [hp_X] in 1 mL
Sodium Sulfate (Sodium Cation)	Sodium Sulfate	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	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
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	15 [hp_X] in 1 mL
Datura Stramonium (Datura Stramonium)	Datura Stramonium	15 [hp_X] in 1 mL
Matricaria Recutita (Matricaria Recutita)	Matricaria Recutita	3 [hp_X] in 1 mL
Passiflora Incarnata Flowering Top (Passiflora Incarnata Flowering Top)	Passiflora Incarnata Flowering Top	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:55714-2252-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2252-2	59.14 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, API MANUFACTURE

Revised: 03/2011

Document Id: 34da6d11-70c6-51e7-d24a-526a76d91d6e

Set id: 34d7eb92-6667-a8dc-c833-a0d995e16c2c

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.