What is it used for?
(Traditionally) used in Herbal Medicine to help relieve digestive upset including bloating and flatulence [Source note 2].
(Traditionally) used in Herbal Medicine to help relieve the pain associated with menstruation [Source note 3].
(Traditionally) used in Herbal Medicine as an expectorant to help relieve coughs associated with colds [Source note 4].
The above uses 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 the pain associated with menstruation and digestive upset including bloating and flatulence).
For multi-ingredient products:
What this guide covers
The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.
Who does this guide cover?
Children 4-11 years, Adolescents 12-17 years, Adults 18 years and older [Source note 5].
How is it taken?
Oral
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 4-5 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
Children 4-11 years
Methods of preparation: Dry¹, Non-Standardized Aqueous Extracts (Dry extract, Infusion, Infusion concentrate)
3 - 5 grams of dried fruit/seed, per day; Not to exceed 1.6 grams per single dose [Source note 6].
¹Note: Dried fruit/seed should be prepared as an infusion (see direction for use).
Adolescents 12-17 years; Adults 18 year and older
Methods of preparation: Dry, Powdered, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
1.2 grams of dried fruit/seed, per day; Not to exceed 0.4 grams per single dose [Source note 7].
Methods of preparation: Dry¹, Non-Standardized Aqueous Extracts (Dry extract, Infusion, Infusion concentrate)
4.5 - 7.5 grams of dried fruit/seed, per day; Not to exceed 2.5 grams per single dose [Source note 8].
¹Note: Dried fruit/seed should be prepared as an infusion (see direction for use).
How is it used?
Dried fruits/seeds
Pour 250 ml (1 cup) of boiling water over fruit/seed and infuse for 15 minutes [Source note 9].
How long is it used?
Children 4-11 years
Ask a healthcare professional for use beyond 1 week [Source note 10].
Adolescents 12-17 years; Adults 18 years and older
Ask a healthcare professional for use beyond 2 weeks [Source note 11].
Warnings and precautions
Ask a healthcare professional if symptoms persist or worsen.
Ask a healthcare professional before use if you are pregnant or breastfeeding [Source note 12].
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 13].
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) |
|---|---|---|---|---|
| Foeniculum vulgare subsp. vulgare var. dulce |
| Foeniculum vulgare subsp. vulgare var. dulce |
| Dry |
References: Proper name: USDA 2024; EMA 2007; Common names: USDA 2024; EMA 2024; Source information: EMA 2024.
¹The term 'seed' for fennel is commonly used to refer to the dried fruit.
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
- November 29, 2024
- 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.