FDA Label for Cold Flu Relief Elderberry

View Indications, Usage & Precautions

Cold Flu Relief Elderberry 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.

Active Ingredients



Pelargonium sidoides 1x

Aconitum napellus 4x 

Eucalyptus globulus 2x

Sambucus nigra 3x

Bryonia 4x 

Eupatorium perfoliatum 6x 

Gelsemium sempervirens 4x 

Phosphorus 6x

Ipecacuanha 3x 


Inactive Ingredients



Citric Acid

Elderberry Extract

Ethyl Alcohol 

Glycerin

Lactose Monohydrate

Maltodextrin

Natural Flavor

Potassium Sorbate

Purified Water

Sorbitol


Indications & Usage



Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing, stuffy/runny nose, nasal congestion.


Dosage & 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 & children 13 years of age and older: take 1½ teaspoons (tsp) (7.5 mL) three times daily.

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

Children under 6 years of age: consult a doctor.


Purpose



Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing, stuffy/runny nose, nasal congestion.


Warnings



Sore throat warning: if sore throat is severe or 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 Geraniaceae 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 then 7 days or occurs with rash or persistent headache. 

These could be signs of a serious condition.


Pregnancy Or Breastfeeding



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.


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