To prevent the product from being represented as a “traditional medicine”, any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Calendula is traditionally used in Herbal Medicine to help relieve minor mucous membrane inflammations of the mouth and throat)
When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required
Approved Dose Ranges
1
Population
Dose Range
Frequency
Adolescents 12-17 years, Adults 18 years and older (EMA 2018).
2–100 %
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Cautions & Contraindications
3
cautionAsk a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (EMA 2018).
cautionStop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen or last (for) more than 7 days (EMA 2018).
adverse_reactionStop use if hypersensitivity/allergy occurs (Brinker 2010; Mills and Bone 2005).