(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (which helps to promote sleep) (nervine/calmative)
(Traditionally) used in Herbal Medicine to help relieve symptoms of mild digestive disturbances/dyspepsia/indigestion (such as upset stomach, bloating and flatulence)
The above claims can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g. Traditionally used in Herbal Medicine to help relieve restlessness or nervousness and to help relieve digestive disturbances)
For multi-ingredient products:
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. Lemon balm is traditionally used in Herbal Medicine to help relieve digestive disturbances)
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 to 17 years and Adults 18 years and older (EMA 2014)
0.4–13.5 grams
per day
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 2014).
cautionWhen using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2014).
cautionAsk a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.