Appetite 4537P-Dis

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 4537P-Dis

INDICATIONS & USAGE SECTION

Appetite - Craving Control   Formulated for symptoms associated with compromised glucose metabolism 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.       

ACTIVE INGREDIENT SECTION

Anacardium orientale 20x, Antimon. crud. 20x, Arg. nit.20x, Berber. vulg. 20x, Bryonia 20x, Chelidonium majus 20x, Digitalis 20x, Graphites 20x, Humulus 20x, Iris versicolor 20x, Kali carb. 20x, Lycopodium 20x, Nat. carb. 20x, Nat. sulphuricum 20x, Nux vom. 20x,  Pulsatilla 20x, Rhus toxicodendron 20x, Scutellaria lateriflora 20x, Sepia 20x, Stramonium 20x, Chamomilla 8x, Passiflora 8x, Valeriana 8x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.    

PURPOSE SECTION

Formulated for symptoms associated with compromised glucose metabolism 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.     

 PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.                   

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 PRESCRIPTION DRUGItem Code (Source)NDC: 55714-4537
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE20 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE20 [hp_X]  in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE20 [hp_X]  in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK20 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT20 [hp_X]  in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS20 [hp_X]  in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS20 [hp_X]  in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE20 [hp_X]  in 1 g
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS20 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT20 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE20 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE20 [hp_X]  in 1 g
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE20 [hp_X]  in 1 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE20 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED20 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS20 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF20 [hp_X]  in 1 g
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA20 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE20 [hp_X]  in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM20 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA8 [hp_X]  in 1 g
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP8 [hp_X]  in 1 g
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN8 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-4537-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/01/201101/31/2019
2NDC: 55714-4537-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4537)

Revised: 1/2019
 
Newton Laboratories, Inc.