Hypothalmus Tincture
FDA Label NDC 57520-0288

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Hypothalmus Tincture (NDC 57520-0288). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENTS:  Aralia quinquefolia 3X, Hydrocotyle asiatica 3X, Polygonum multiflorum 3X, Hypothalamus 8X, Pituitarum posterium 8X, Germanium sesquioxide 12X, Pineal 14X.

Otc - Purpose

INDICATIONS:  Provides a specific sarcode support for the hypothalamus-pituitary-pineal axis.  Gives temporary relief of weakness, exhaustion, vertigo and difficult mental concentration.

Warnings

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.

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


Dosage & Administration

DIRECTIONS:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.


Inactive Ingredient

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.


Otc - 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.


Indications & Usage

INDICATIONS:  Provides a specific sarcode support for the hypothalamus-pituitary-pineal axis.  Gives temporary relief of weakness, exhaustion, vertigo, and difficult mental concentration.

Otc - Questions

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322



Package Label.Principal Display Panel

Synergy Formulas

HYPOTHALAMUS TINCTURE

HOMEOPATHIC

2 FL OZ (60 ml)

Hypothalamus Tincture (Mm1)

Hypothalamus Tincture (Mm1)

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