MedPath

Serotonin

DRUG FACTS:

Approved
Approval ID

396ace51-5d9b-4e76-a8d0-f3c9f53b523b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

BioActive Nutritional, Inc.

DUNS: 624980496

Products 1

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

Serotonin (Hydrochloride)

PRODUCT DETAILS

NDC Product Code43857-0245
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 21, 2025
Generic NameSerotonin (Hydrochloride)

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SEROTONIN HYDROCHLORIDEActive
Quantity: 6 [hp_X] in 1 mL
Code: GKN429M9VS
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

PACKAGE LABEL DISPLAY:

BIOActiveNutritional

SEROTONIN

HOMEOPATHIC

2 fl. oz. (60mL)

SEROTONIN

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2025

USES:

For temporary relief of nervousness, anxiety, mood swings, joint pains, weakness, drowsiness, itching & lethargy.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/21/2025

ACTIVE INGREDIENTS:

Serotonin 6X, 12X, 30X, 12C, 30C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/21/2025

PURPOSE:

Serotonin - mood**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2025

WARNINGS:

**​If pregnant or breast-feeding,**​ ask a health care 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: 5/21/2025

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: 5/21/2025

DIRECTIONS:

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/21/2025

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/21/2025

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

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Serotonin - FDA Approval | MedPath