MedPath

Emotional Eating

DRUG FACTS:

Approved
Approval ID

e57a1619-a5be-43a8-8edc-02c6cf67dbeb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Dr. Donna Restivo DC

DUNS: 790796940

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Equol, Pantothenic Acid, Rhodiola, Stomach (Suis), Chininum Sulphuricum, Iodium, Lycopodium Clavatum, Phosphorus, Dopamine Hydrochloride, Thyroidinum (Suis), Cina, Serotonin (Hydrochloride), Oxytocin, Gambogia, Morgan Gaertner

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62185-0059
Product Classification
G
Generic Name
Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Equol, Pantothenic Acid, Rhodiola, Stomach (Suis), Chininum Sulphuricum, Iodium, Lycopodium Clavatum, Phosphorus, Dopamine Hydrochloride, Thyroidinum (Suis), Cina, Serotonin (Hydrochloride), Oxytocin, Gambogia, Morgan Gaertner
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (20)

EQUOL, (+/-)-Active
Quantity: 6 [hp_X] in 1 mL
Code: 2RZ8A7D0E8
Classification: ACTIB
PANTOTHENIC ACIDActive
Quantity: 6 [hp_X] in 1 mL
Code: 19F5HK2737
Classification: ACTIB
SEDUM ROSEUM ROOTActive
Quantity: 6 [hp_X] in 1 mL
Code: 3S5ITS5ULN
Classification: ACTIB
SUS SCROFA STOMACHActive
Quantity: 6 [hp_X] in 1 mL
Code: T0920P9Z9A
Classification: ACTIB
QUININE SULFATEActive
Quantity: 6 [hp_X] in 1 mL
Code: KF7Z0E0Q2B
Classification: ACTIB
IODINEActive
Quantity: 6 [hp_X] in 1 mL
Code: 9679TC07X4
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 6 [hp_X] in 1 mL
Code: C88X29Y479
Classification: ACTIB
PHOSPHORUSActive
Quantity: 6 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
DOPAMINE HYDROCHLORIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
ARTEMISIA CINA PRE-FLOWERING TOPActive
Quantity: 8 [hp_X] in 1 mL
Code: 28M1820ACT
Classification: ACTIB
GAMBOGEActive
Quantity: 14 [hp_X] in 1 mL
Code: 7556HJ7587
Classification: ACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDISActive
Quantity: 30 [hp_C] in 1 mL
Code: Y3V16D4PV4
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ADENOSINE TRIPHOSPHATE DISODIUMActive
Quantity: 6 [hp_X] in 1 mL
Code: 5L51B4DR1G
Classification: ACTIB
SEROTONIN HYDROCHLORIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: GKN429M9VS
Classification: ACTIB
THYROIDActive
Quantity: 6 [hp_X] in 1 mL
Code: 6RV024OAUQ
Classification: ACTIB
OXYTOCIN ACETATEActive
Quantity: 12 [hp_X] in 1 mL
Code: 4NR672T8NL
Classification: ACTIB
SUS SCROFA ADRENAL CORTEXActive
Quantity: 6 [hp_X] in 1 mL
Code: 0G750PYD4W
Classification: ACTIB
BACOPA MONNIERI WHOLEActive
Quantity: 6 [hp_X] in 1 mL
Code: DUB5K84ELI
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/8/2025

PACKAGE LABEL DISPLAY:

Dr. Donna Restivo DC

Wellness Consultant

NDC 62185-0059-1

HOMEOPATHIC

Emotional Eating

1 FL OZ (30 ml)

Emotional Eating

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/22/2020

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms including constant appetite, increased or insatiable hunger.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/22/2020

DIRECTIONS:

3-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/8/2025

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/8/2025

ACTIVE INGREDIENTS:

Adenosinum Triphosphoricum Dinatrum 6X, 8X, Adrenal Cortex (Suis) 6X, 8X, Bacopa Speciosa 6X, 8X, Equol 6X, 8X, Pantothenic Acid 6X, 8X, Rhodiola 6X, 8X, Stomach (Suis) 6X, 8X, Chininum Sulphuricum 6X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Iodium 6X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Lycopodium Clavatum 6X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Phosphorus 6X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Dopamine Hydrochloride 8X, Thyroidinum (Suis) 8X, Cina 8X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Serotonin (Hydrochloride) 8X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Oxytocin Acetate 12X, Gambogia 14X, Morgan Gaertner 30C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/22/2020

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms including constant appetite, increased or insatiable hunger.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS SECTION

LOINC: 34071-1Updated: 3/10/2021

WARNINGS:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: Sealed for your protection. Do not use if seal is broken or missing.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/10/2021

INACTIVE INGREDIENTS:

demineralized water, 25% ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/22/2020

QUESTIONS:

Distributed by Dr. Donna Restivo DC, Wellness Consultant

822 South Lake Blvd, Mahopac, New York 10541

www.mahopacmassage.com • (845) 628-6286

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Emotional Eating - FDA Drug Approval Details