Thyreoidea Compositum
FDA Label NDC 50114-7041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Thyreoidea Compositum (NDC 50114-7041). 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 description, indications and usage, dosage and administration, warnings and precautions, overdoasge, clinical pharmacology, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description


Injection Solution Ingredient Information: Each 2.2ml ampule contains: Sarcolacticum acidum 3X, Viscum album 3X, Colchicum autumnale 4X, Conium maculatum 4X, Galium aparine 4X, Fucus vesiculosus 6X, Sedum acre 6X, Sempervivum tectorum 6X, ATP Adenosine triphosphate 8X, Fumaricum acidum 8X, α-Ketoglutaricum acidum 8X, Malicum acidum 8X, Natrum oxalaceticum 8X, Pulsatilla 8X, Spongia tosta 8X, Thyreoidea suis 8X, Calcarea fuorica 10X, Funiculus umbilicalis suis 10X, Hepar suis 10X, Medulla ossis suis 10X, Splen suis 10X, Sulphur 10X, Thymus suis 10X, Cortisone aceticum 28X 22mcl each. Inactive ingredient: Sterile isotonic sodium chloride solution.

Indications And Usage

Thyreoidea compositum® Injection Solution is indicated for stimulation of the defense system in thyroid dysfunction, connective tissue dysfunction and glandular dysfunction.

Dosage And Administration

The dosage schedules listed below can be used as a general guide for the administration of Thyreoidea compositum® Injection Solution. Thyreoidea compositum® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient’s response to therapy. Adults and children 7 years and older: in acute disorders, 1 ampule per day, otherwise 1 ampule, 1 to 3 times per week IM/SC/IV/ID.Children ages 2 to 6 receive ½ the adult dosage.         Discard unused solution.Thyreoidea compositum® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Thyreoidea compositum® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefy. Thyreoidea compositum® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Thyreoidea compositum® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Thyreoidea compositum® Injection Solution is a clear, colorless solution. Discolored solutions should be discarded.

Warnings And Precautions

If pain persists or worsens,  if new symptoms occur, or if redness or swelling is present, the patient should be carefully re-evaluated because  these could be signs of a serious condition.

Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Overdoasge

Due to the low concentration of active ingredients in homeopathic preparations such as Thyreoidea compositum® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

Clinical Pharmacology

The exact mechanism of action of Thyreoidea compositum®Injection Solution is not fully understood.

Package Label.Principal Display Panel

ThyreoideaComp_Inj_Box.jpg

* Please review the disclaimer below.