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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2253
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE15 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE15 [hp_X]  in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE15 [hp_X]  in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS15 [hp_X]  in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS15 [hp_X]  in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE15 [hp_X]  in 1 g
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS15 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT15 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 g
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE15 [hp_X]  in 1 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 g
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA15 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM15 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 g
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2253-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2253-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2253-07.08 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2253)

Revised: 1/2019