FDA Label for Umcka Elderberry
View Indications, Usage & Precautions
Umcka 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.
Otc - Active Ingredient
Active Ingredients:
Aconitum napellus 4x
Bryonia alba 4x
Eucalyptus globulus 2x
Eupatorium perfoliatum 2x
Gelsemium sempervirens 4x
Ipecacuanha 3x
Pelargonium sidoides 1x
Phosphorus 6x
Sambucus nigra 3x
Inactive Ingredient
Inactive Ingredients:
Alcohol (0.45%)
Citric acid
Elderberry extract
Lactose
Maltodextrin
Natural Raspberry flavor
Purified water
Sorbitol
Vegetable-source glycerin
Indications & Usage
Purpose:
Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations.
Dosage & Administration
Directions:
For best results, use at first sign of symptoms.
Continue to use for an additional 48 hours after symptoms cease.
Adults and children 12 years of age and older: take 1 1/2 teaspoons (7.5 mL) three times daily.
Children 6 to 11 years of age: take 1 teaspoon (5mL) three times daily.
Children under 6 years of age: consult a doctor.
Warnings
Warnings:
Sore throat warning: SEvere or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serious.
Consult a doctor promptly.
Ask a doctor before use if you have: persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if: new symptoms occur, symptoms get worse or last more then 7 days, cough lasts more then 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Purpose:
Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations:
chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose
Umcka Elderberry Intensive Cold + Flu Syrup 4 Oz. (15845)
UMCKA 15845_CF_ELDERBERRY_05.jpg
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