Otc - Active Ingredient
ACTIVE INGREDIENTS:
Aconitum napellus 3X
Hepar sulphuris calcareum (Calcium Sulfide) 12X
Spongia tosta 3X
Stannum metallicum (Tin) 12X
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Bronchial And Breathing Aide (NDC 53499-9498). 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, inactive ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS:
Aconitum napellus 3X
Hepar sulphuris calcareum (Calcium Sulfide) 12X
Spongia tosta 3X
Stannum metallicum (Tin) 12X
INACTIVE INGREDIENTS
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
PURPOSE:
Uses: Helps loosen phlegm (mucus) and thins bronchial secretions, relieves bronchial congestion
Directions: Sublingual medication.
Place tablets under tongue at least 15 minutes before or half hour after eating, brushing teeth, or drinking anything except water.
Adults and children 12 years of age and older: 2 tablets every two hours until relieved.
Children under 12 years of age: Consult a doctor.
INDICATIONS AND USAGE:
Helps loosen phlegm (mucus) and thins bronchial secretions, relieves bronchial congestion.
WARNINGS:
Sore Throat Warning: Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.
Consult a physician promptly.
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
Children:
Keep out of the reach of children.
Ask the Doctor:
Before use if you have a persisient or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emplysema or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptons occur, symptoms worsen or do not get better within 7 days for adults or 5 days for children, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with a rash or persistent headache.
These could be signs of a serious condition.
Overdosage:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
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