FDA Label for Nightime Cough And Bronchial

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
INACTIVE INGREDIENT
DOSAGE AND ADMINISTRATION SECTION
WARNINGS
OTC - KEEP OUT OF REACH OF CHILDREN
OTC - PREGNANCY OR BREAST FEEDING
OVERDOSE:
INDICATIONS AND USAGE SECTION
OTC PURPOSE SECTION
PACKAGE LABEL PRINCIPAL DISPLAY PANEL21900694.A03 NIGHTTIME COUGH AND BRONCHIAL SYRUP

Nightime Cough And Bronchial Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Broecke and Tafel Brand

Active Ingredients:

Acontinum napellus 3X

Alfalfa 1X Imedicago sativa leaf)

Coffea cruda 6X (arabica coffee bean)

Avena sativa 1X (oat)

Bryonia Alba Root 3X

Hepar sulphuris calcareum 6C (calcium)

Spongia tosta 3X (spongia officinalis skeleton roasted)

Stannum metallicum 6C (tin)

Inactive Ingredient

Inactive Ingredients: Citrc Acid, Alcohol (10.5%), Malt Extract, Purified Water, Sodium Benzoate, Sucrose

Dosage And Administration Section

Recommendations:

Adults and children 12 years of age and older: 2 teaspoons (10mL) 1/2 hour before bedtime.

Dosage may be repeated if necessary.

Children under 12: Ask a doctor.

Warnings

Warnings:

Sore Throat Warning: Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting or rash may be serious.

Consult a physician promptly.

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, emphysema, or chronic bronchitis; cough is accompanied by excessive phlegm (mucus).

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children

Otc - Pregnancy Or Breast Feeding

Pregnancy or Breast feeding:

Ask a healthcare professional before use.

Overdose:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Indications And Usage Section

Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.

Soothes the throat.

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Otc Purpose Section