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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43857-0245
Product Classification
G
Generic Name
Serotonin (Hydrochloride)
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

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 Drug Approval Details