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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