FDA Label for Sambucus Flu Relief

View Indications, Usage & Precautions

Sambucus Flu Relief 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 Ingredient



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

Fructose

Glycerin

Lactose Monohydrate

Natural Flavor

Purified Water


Dosage & Administration



Directions:

For best results, use at first sign of symptoms and continue to use for an additonal 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 2 teaspoons (tsp) (10 mL) four times daily.

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

Children under 6 years of age: Consult a doctor.


Indication & Usage



Temporarily relieves common flu symptoms: chills/ fever, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, body aches.


Purpose



Temporarily relieves common flu symptoms: chills/ fever, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, body aches.


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.


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.


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