What is it used for?
Used in Herbal Medicine to help relieve inflammatory conditions of the gastrointestinal tract [Source note 3].
(Traditionally) used in Herbal Medicine to help relieve mild digestive upset (such as dyspepsia, flatulence, bloating and belching) (Mills and Bone 2005; ESCOP 2003; Bradley 1992; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (which helps to promote sleep) (nervine/calmative) (Blumenthal et al. 2000; WHO 1999; Bradley 1992; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).
The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g., Used in Herbal Medicine to help relieve inflammatory conditions of the gastrointestinal tract and mild digestive upset).
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 active 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., Chamomile is traditionally used in Herbal Medicine to help relieve restlessness).
When ALL of the active 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.
What this guide covers
Text in parentheses is additional optional information which can be included on the label at the applicants' discretion.
Who does this guide cover?
As specified below.
How is it taken?
Oral [Source note 2].
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Acceptable dosage forms by age group:
Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006). Children 3-5 years:The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006). Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The
Quantities
Methods of preparation: Dry, Powdered, Non-Standardized Extracts (Dry extract*, Tincture, Fluid extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)
| Subpopulation(s)¹,² | Subpopulation(s)¹,² | Chamomile dried flower (g/day) / Minimum | Chamomile dried flower (g/day) / Maximum |
|---|---|---|---|
| Children | 2-4 years | 0.3 g | 4.0 g |
| Children | 5-9 years | 0.4 g | 6.0 g |
| Children | 10-11 years | 0.8 g | 12.0 g |
| Adolescents | 12-14 years | 0.8 g | 12.0 g |
| Adolescents | 15-17 years | 1.5 g | 24.0 g |
| Adults | 18 years and older | 1.5 g | 24.0 g |
¹Children and adolescent doses were calculated as a proportion of the adult dose [Source note 4]. The use of German chamomile in children and adolescents is supported by the following references: Schilcher 1997; Bove 1996. ²Adult dose supported by the following references: Mills and Bone 2005; ESCOP 2003; Blumenthal et al. 2000; WHO 1999; Bradley 1992.
*Note: Solvents allowed for the method of preparation “Non-standardized extracts (Dry extract)” as part of this reference are ethanol and/or water only.
How is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
When using this product exercise caution if you drive or use machinery as you may experience drowsiness.
Ask a healthcare professional if symptoms persist or worsen.
When should it be avoided?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Possible side effects
Stop use if hypersensitivity/allergy occurs [Source note 5].
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) | Source information / Preparation(s) |
|---|---|---|---|---|
| Matricaria chamomilla |
| Matricaria chamomilla | Flower | Dry |
References: Proper name: USDA 2024; Common names: USDA 2024; Gardner and McGuffin 2013; Source information: Mills and Bone 2005; ESCOP 2003; Blumenthal et al. 2000; WHO 1999; Bradley 1992.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- December 19, 2025
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
Taking a medication too?
Explore our supplement–medication interaction checker. Its coverage and review status are shown with the results; a missing finding does not establish that a combination is safe.
