Placenta Compositum
FDA Label NDC 50114-7055

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 Placenta Compositum (NDC 50114-7055). 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, indication and usage, dosage and administration, warnings, 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 2.2 ml ampule contains: Aesculus hippocastanum 4X, Sarcolacticum acidum 4X, Secale cornutum 4X, Cuprum sulphuricum 6X, Melilotus officinalis 6X, Placenta suis 6X, Solanum nigrum 6X, Strophanthus hispidus 6X, Embryo suis 8X, Natrum pyruvicum 8X, Vena suis 8X, Arteria suis 10X, Funiculus umbilicalis suis 10X, Tabacum 10X, Vipera berus 10X, Baryta carbonica 13X, Plumbum iodatum 18X 22 mcl each. Inactive ingredient: Sterile isotonic sodium chloridesolution

Indication And Usage

Placenta compositum Injection Solution is indicated for stimulation of metabolic functions of the peripheral circulation of the blood as well as for a revitalizing and stimulating effect on the liver and peripheral vascular system.Placenta compositum Injection Solution is classified as a homeopathic combination drug.Botanical ingredients:    Aesculus hippocastanum (horse chestnut)    Melilotus officinalis (yellow sweet clover)    Secale cornutum (rye ergot)    Solanum nigrum (black nightshade)    Strophanthus hispidus (Strophanthus)    Tabacum (tobacco)Mineral ingredients:    Baryta carbonica (barium carbonate)    Cuprum sulphuricum (copper sulfate)    Natrum pyruvicum (sodium pyruvate)    Plumbum iodatum (lead iodide)    Sarcolacticum acidum (L-lactic acid)Animal-derived ingredients    Arteria suis (porcine artery)    Embryo suis (porcine embryo)    Funiculus umbilicalis suis (porcine umbilical cord)    Placenta suis (porcine placenta)    Vena suis (porcine vein)    Vipera berus (common viper)

Dosage And Administration

The dosage schedules listed below can be used as a general guide for the administration of Placenta compositum Injection Solution. Placenta 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.

Warnings

Warnings and PrecautionsIf 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

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