Active Ingredient
Aconitum napellus 4X
Eucalyptus globulus 2X
Sambucus nigra 3X
Bryonia 4X
Eupatorium perfoliatum 6X
Gelsemium sempervirens 4X
Phosphorus 6X
Ipecacuanha 3X
Sambucus Flu Relief Syrup
FDA Label NDC 53499-0803
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Sambucus Flu Relief (NDC 53499-0803). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, dosage & administration, indication & usage, purpose, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
