Asthmacare
FDA Label NDC 57955-7044

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 Asthmacare (NDC 57955-7044). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

HPUS active ingredients

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

Aconitum napellus, Adrenalinum, Ammonium carbonicum, Antimonium tartaricum, Aralia racemosa, Bromium, Chlorinum, Eriodictyon Californicum, Eucalyptus globulus, Grindelia, Lobelia inflata, Natrum sulphuricum, Phosphorus, Quebracho, Trifolium pratense.

Otc - Purpose

HPUS active ingredients                                           Purpose †

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

Aconitum napellus....................................................shortness of breath

Adrenalinum.............................................................asthma related congestion

Ammonium carbonicum.............................................breathing difficulties

Antimonium tararicum...............................................shortmess of breath

Aralia racemosa........................................................tightness in chest

Bromium..................................................................spasmodic cough

Chlorinum................................................................tightness in chest

Eriodictyon californicum.............................................asthmatic wheezing

Eucalyptus globulus..................................................mucus congestion

Grindelia.................................................................bronchial irritation

Lobelia inflata..........................................................cough, chest discomfort

Natrum sulphuricum.................................................shortness of breath

Phosphorus.............................................................asthmatic chest spasms

Quebracho..............................................................shortness of breath

Trifolium pratense....................................................tracheal irritation

Indications & Usage

Uses

For temporary relief or minor asthma symptoms such as:

  • shortness of breath
  • tightness in chest
  • wheezing
  • bronchial irritation
  • cough
  • minor breathing difficulties
  • † as per various homeopathic Materia Medicas.

Warnings

Warnings

  • This product is not a rescue inhaler.
  • Asthma can be life threatening. If you have ever been hospitalized for asthma, consult a physician before using this product. This product is intended to complement, not replace, standard medical treatment.
  • Children with asthma should be under the ongoing supervision of a physician.
  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

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.

Other Safety Information

Other information:

Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredient

Inactive Ingredients: Citric acid, Potassium sorbate and Purified water.

Package Label.Principal Display Panel

Image Description (Asthmacare)

Image Description (Asthmacare)

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