Appetite 2253P

Drug Labeling and Warnings

Drug Details [pdf]

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. pellet 
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.

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Appetite 2253P

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:  Ages 12 and up, take 6 pellets orally (ages 6 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 pellet 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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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

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. pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2253
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	15 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	15 [hp_X]  in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	15 [hp_X]  in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X]  in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	15 [hp_X]  in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X]  in 1 g
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	15 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	15 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X]  in 1 g
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	15 [hp_X]  in 1 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X]  in 1 g
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	15 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X]  in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	15 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 1 g
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2253-1	28.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
2	NDC: 55714-2253-2	56.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
3	NDC: 55714-2253-0	7.08 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-2253)

Revised: 1/2019

Document Id: 909498bf-20b2-d178-e053-2995a90a376b

34390-5

Set id: 0ee52c68-a5d9-5646-6977-68ee6ad66b7c

Version: 3

Effective Time: 20190131