FDA Label for Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root

View Indications, Usage & Precautions

Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc.. 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.

Active Ingredients



Pelargonium sidoides 1X

Aconitum napellus 3X

Bryonia 3X 

Hepar sulphuris calcareum 6C

Stannum metallicum 6C

Spongia tosta 3X


Inactive Ingredients



Citric Acid

English Ivy Leaf Extract

Ethyl Alcohol 

Glycerin

Lactose Monohydrate

Maltodextrin

Potassium Sorbate

Purified Water

Sorbitol


Purpose



Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion.

Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.


Indications & Usage



Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion.

Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.


Doage & Administration



Directions

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Shake well before each use.

Use only with enclosed dosage cup.

Adults and Children 13 years of age and older:  Take 1 ½ teaspoons (tsp) (7.5 mL) three times daily.

Children 6 to 12 years of age:  Take 1 teaspoon (5 mL) three times daily.

Children under 6 years of age: Consult a doctor.


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 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, an allergy to plants of the Genaniaceae family.


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 a sign of a serious condition.


Overdose



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


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.  


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