Respiratorycare
FDA Label NDC 57955-4053

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc for the product Respiratorycare (NDC 57955-4053). 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 active ingredients, inactive ingredients, directions, purpose, warnings, otc - keep out of reach of children, indications and usage, 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

Active Ingredients

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

Ammonium carbonicum, Antimonium tartaricum, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Phosphorus, Silicea, and Stannum metallicum.

Reference image respiratorycare.jpg

Inactive Ingredients

Citric acid, potassium sorbate, and purified water.

Reference image respiratorycare.jpg

Directions

Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult Dose: 3 pump sprays 3 times per day.

Children 6 -12 years: 2 pump sprays 3 times per day.

Use additionally as needed, up to 6 times per day.

Reference image respiratorycare.jpg

Purpose

HPUS active ingredients                                       Purpose

Equal volumes of each ingredient in 10X, 30X and LM1

Ammonium carbonicum....................................................labored breathing

Antimonium tartaricum.....................................................bronchial mucus

Carbo vegetabilis.............................................................wheezing, chest discomfort

Chlorinum.......................................................................bronchial irritation

Kali carbonicum..............................................................bronchial inflammation

Lobelia inflata..................................................................labored breathing

Phosphorus....................................................................lung congestion, cough

Silicea............................................................................shortness of breath, excess mucus

Stannum metallicum........................................................cough, hoarseness

Reference image respiratorycare.jpg

Warnings

  • This product is not a rescue inhaler.
  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.
  • Keep out of reach of children.

    • Other information: Tamper resistant for your protection. Use only if safety seal is intact.

    Reference image respiratorycare.jpg

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications And Usage

Uses for temporary relief of respiratory symptoms such as:

  • lung and bronchial congestion
  • wheezing
  • bronchial irritation
  • excess mucus
  • spasmodic cough
  • minor shortness of breath
  • cough
  • hoarseness
  • minor bronchial inflammation
    • as per various homeopathic Materia Medicas.

    Reference image respiratorycare.jpg

Package Label.Principal Display Panel

Image Of Carton (Respiratorycare)

Image Of Carton (Respiratorycare)


King Bio, Inc

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.safe-care.com


* Please review the disclaimer below.