FDA Label for Sambucus Flucare
View Indications, Usage & Precautions
Sambucus Flucare 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.
Otc - Active Ingredient
ACTIVE INGREDIENTS:
Aconitum napellus 4X
Eucalyptus globulus 2X
Sambucus nigra 3X
Bryonia 4X
Eupatorium perfoliatum 6X
Gelsemium sempervirens 4X
Phosphorus 6X
Ipecacuanha 3X
Inactive Ingredient
INACTIVE INGREDIENT:
Citric acid
Elderberry extract
Ethyl Alcohol (0.6%)
Fructose
Vegetable-source Glycerin
Lactose
Natural Raspberry flavor
Purified Water
Dosage & Administration
Dosage and Administration:
Directions: For best results, use at first sign of symptoms.
Use only with enclosed dosage cup
Adults and children 12 years of age and older: Take 2 teaspoons (10 mL) four times daily.
Children 6-11 years of age: take 1 teaspoon (5 mL) four times daily.
Children under 6 years of age: Consult a physician.
Indications & Usage
Indication and Usage:
Temporarily relieves common flu symptoms: chills and fevers, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, minor aches and pains.
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 such as occurs with smoking, asthma or emphysema; a cough accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days; fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.
This could be signs of a serious condition.
If pregnant or breast-feeding, ask a healthcare professoinal before use.
Keep out of reach of children.
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Otc - Pregnancy Or Breast Feeding
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:
Keep out of reach of children.
Otc - Ask Doctor
Ask the Doctor:
Ask a doctor before use if you have persistent or chronic cough that lasts, or a chronic cough such as occurs with smoking, asthma or emphysema or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days; cough lasts more than 7 days or occurs with rash or persistent headache; fever worsens or lasts more than 3 days.
This could be signs of a serious condition.
Overdosage
Overdose:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Otc - Purpose
Purpose:
Temporarily relieves common flu symptoms: chills and fevers, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, minor aches and pains.
Package Label And Principal Display: 15803 Sambucus Flucare Syrup
Sambucus 15803 FluCare Syrup 4 oz
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