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8 Small Intestine

DRUG FACTS:

Approved
Approval ID

63c61f04-3a3b-4818-b387-d99b7899b1f2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

The Wellness Center

DUNS: 832363993

Products 1

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

Condurango, Phytolacca Decandra, Aconitum Napellus, Aurum Metallicum, Graphites, Hydrastis Canadensis, Mercurius Vivus, Sulphur, Pulsatilla

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50181-0029
Product Classification
G
Generic Name
Condurango, Phytolacca Decandra, Aconitum Napellus, Aurum Metallicum, Graphites, Hydrastis Canadensis, Mercurius Vivus, Sulphur, Pulsatilla
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
MARSDENIA CONDURANGO BARKActive
Quantity: 3 [hp_X] in 1 mL
Code: R23QIR6YBA
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 1 [hp_M] in 1 mL
Code: U0NQ8555JD
Classification: ACTIB
GOLDActive
Quantity: 1 [hp_M] in 1 mL
Code: 79Y1949PYO
Classification: ACTIB
GOLDENSEALActive
Quantity: 1 [hp_M] in 1 mL
Code: ZW3Z11D0JV
Classification: ACTIB
SULFURActive
Quantity: 1 [hp_M] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
PULSATILLA VULGARISActive
Quantity: 10 [hp_M] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PHYTOLACCA AMERICANA ROOTActive
Quantity: 3 [hp_X] in 1 mL
Code: 11E6VI8VEG
Classification: ACTIB
GRAPHITEActive
Quantity: 1 [hp_M] in 1 mL
Code: 4QQN74LH4O
Classification: ACTIB
MERCURYActive
Quantity: 1 [hp_M] in 1 mL
Code: FXS1BY2PGL
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

PACKAGE DISPLAY LABEL:

Dr. Theresa Dale's

NDC: 50181-0029-1

​N​euro-​E​motional​R​emedies

#8 SMALL INTESTINE Vulnerable

1 fl oz (30 ml)

8 Small Intestine

8 Small Intestine

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/3/2013

INDICATIONS:

For the temporary relief of feeling vulnerable and feeling lost.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/3/2013

ACTIVE INGREDIENTS:

Condurango 3X, Phytolacca Decandra 3X, Aconitum Napellus 1M, Aurum Metallicum 1M, Graphites 1M, Hydrastis Canadensis 1M, Mercurius Vivus 1M, Sulphur 1M, Pulsatilla (Vulagaris) 10M

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/3/2013

INDICATIONS:

For the temporary relief of feeling vulnerable and feeling lost.

WARNINGS SECTION

LOINC: 34071-1Updated: 11/11/2013

WARNINGS:

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

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/3/2013

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/11/2013

DIRECTIONS:

Feel the emotion fully, breathe deeply-connecting breaths. Put 5 drops under tongue to release emotion. Continue 5 drops 2x daily as needed. Conslult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/3/2013

INACTIVE INGREDIENTS:

Deineralized Water, 25% Ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/3/2013

QUESTIONS:

​MFD FOR:

The Wellness Center for Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

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8 Small Intestine - FDA Drug Approval Details