Testosterone
FDA Label NDC 50845-0113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Liddell Laboratories, Inc. for the product Testosterone (NDC 50845-0113). 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:Avena sativa 1X, Carduus marianus 1X, Damiana 1X, Galium aparine 3X, Hamamelis virginiana 1X, Hepar bovinum 6X, Korean ginseng 1X, Nuphar luteum 2X, Orchitinum bovinum 6X, Populus tremuloides 1X, Testosterone 30X, Thuja occidentalis 200C.

Otc - Purpose

INDICATIONS:  Temporarily supports the body to rebalance testosterone output.  Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

Warnings

WARNINGS:  Not for use on children.  If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician.  Insomnia may be a symptom of a serious underlying medical illness.

As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.

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

TAMPER EVIDENT: There is a seal around the neck of the bottle.  Do not use if this seal is broken or missing.

Dosage & Administration

DIRECTIONS:  Adults:  Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day.  Some people notice improvement within two or three weeks, others take longer.

Inactive Ingredient

INACTIVE INGREDIENTS:  Organic alcohol 30% v/v, Purified water.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

Indications & Usage

INDICATIONS:  Temporarily supports the body to rebalance testosterone output.  Symptoms may include:  poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

Otc - Questions

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Package Label.Principal Display Panel

Testosterone

HOMEOPATHIC

ORGANOTHERAPY

1 FL OZ (30ML)

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Testosterone (Mm1)

Testosterone (Mm1)



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