Vinceel
FDA Label NDC 51885-7500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biologische Heilmittel Heel for the product Vinceel (NDC 51885-7500). 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 purpose, keep out of reach of children, indications and usage, warnings, dosage and administration, active ingredients, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Apis mellifica 7X 0.25 ml....................................Relieves swellingAsclepias vincetoxicum , folia 5X 0.25 ml............Relief of viral symptomsBelladonna 5X 0.25 ml........................................Relieves rednessCalendula officinalis 3X 0.25 ml...........................Relieves pain, promotes wound healingEchinacea purpurea 5X 0.25 ml...........................Provides antiseptic actionPhytolacca decandra 3X 0.25 ml.........................Promotes healing of canker soresPlantago major 3X 0.25 ml..................................Relieves painSalvia officinalis 3X 0.25 ml................................Relieves pain of the gums

Keep Out Of Reach Of Children

Keep this and all medicines out of the reach of children

Indications And Usage

For the temporary relief of:

  • Sore throat
  • Hoarseness
  • Canker sores

Warnings

As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product. Severe or persistent sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by a physician. The use of this dispenser by more than one person may spread infection. Keep this and all medication out of the reach of children. Allergic skin reaction can occur in vary rare cases, in which case use of the product should be discontinued. Do not use in known sensitivity to any of the ingredients of Vinceel.

Dosage And Administration

Adults and children 12 years and over: In general, 1 spray into mouth 3 times daily; in acute conditions spray once every hour, up to 12 times daily

Children under 12 years: Consult a doctor

Active Ingredients

Each 20 ml contains as active ingredients: Apis mellifica 7X 0.25 ml, Asclepias vincetoxicum , folia 5X 0.25 ml, Belladonna 5X 0.25 ml, Calendula officinalis 3X 0.25 ml, Echinacea purpurea 5X 0.25 ml, Phytolacca decandra 3X 0.25 ml, Plantago major 3X 0.25 ml, Salvia officinalis 3X 0.25 ml

Inactive Ingredients

Ethyl alcohol, glycerol, purified water

* Please review the disclaimer below.