Active Ingredient
Acontinum napellus 3X
Alfalfa 1X
Coffea cruda 6X
Avena sativa 1X
Bryonia 3X
Hepar sulphuris calcareum 6C
Spongia tosta 3X
Stannum metallicum 6C
Nightime Cough And Bronchial Syrup
FDA Label NDC 53499-1693
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America for the product Nightime Cough And Bronchial (NDC 53499-1693). 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 ingredient, inactive ingredient, dosage & administration, indications & usage, purpose, warnings, ask a doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
citric acid
ethyl alcohol
malt extract
purified water
sodium benzoate
sucrose
Dosage & Administration
Directions
Shake well before each use.
Adults & Children 12 years of age and older: Take 2 teaspoons (tsp) (10ml) 1/2 hour before bedtime. Dose may be repeated if necessary.
Children under 12 years of age: Consult a doctor
Indications & Usage
Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.
Purpose
Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.
Warnings
Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask A Doctor
Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications.
Stop Use
Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.
These could be signs of a serious condition.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose
In case of overdose, seek medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
