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.
Ingredients and preparations
Bitter fennel fruit/seed
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) | Source information / Preparation(s) |
|---|---|---|---|---|
| Foeniculum vulgare subsp. vulgare var. vulgare |
| Foeniculum vulgare subsp. vulgare var. vulgare |
| Dry |
References: Proper name: USDA 2024; EMA 2024; Common names: USDA 2024; EMA 2024; Source information: EMA 2024.
¹The term ‘seed’ for fennel is often used to refer to the dried fruit.
Bitter fennel essential oil
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) |
|---|---|---|---|
| Foeniculum vulgare subsp. vulgare var. vulgare | Bitter fennel essential oil | Foeniculum vulgare subsp. vulgare var. vulgare |
|
References: Proper name: USDA 2024; EMA 2007; Source information: USDA 2024; EMA 2007.
¹The term ‘seed’ for fennel is commonly used to refer to the dried fruit.
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
What is it used for?
All products (fruit/seed and essential oil)
(Traditionally) used in Herbal Medicine as an expectorant to help relieve coughs associated with colds [Source note 3].
Fruit/Seed (except essential oil)
(Traditionally) used in Herbal Medicine to help relieve digestive upset including bloating and flatulence [Source note 4].
(Traditionally) used in Herbal Medicine to help relieve the pain associated with menstruation [Source note 5].
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). Does not apply to the essential oil as only one claim is associated with it.
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., Bitter fennel is traditionally used in Herbal Medicine as an expectorant to help relieve coughs associated with colds).
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.
Amounts and dosing conditions
ESSENTIAL OIL
Who does this guide cover?
Adults 18 years and older [Source note 6].
Quantities
Method of preparation: Oil, Essential (water steam distillation)
0.2 milliliters of essential oil, per day [Source note 7].
FRUIT/SEED
Who does this guide cover?
Adults 18 years and older [Source note 8].
Quantities
Methods of preparation: Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
0.6 - 2.8 grams of dried fruit/seed, per day [Source note 9].
Who does this guide cover?
Children 4-11 years, Adolescents 12-17 years, Adults 18 years and older [Source note 10].
Quantities
Methods of preparation: Dry¹, Non-Standardized Aqueous Extracts (Dry extract, Infusion, Infusion concentrate)
Children 4-11 years
3 - 5 grams of dried fruit/seed, per day; Not to exceed 1.6 grams per single dose [Source note 11]
Adolescents 12-17 years; Adults 18 years and older
4.5 - 7.5 grams of dried fruit/seed, per day; Not to exceed 2.5 grams per single dose [Source note 12]
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 13].
Conditions for combined preparations
No permitted combinations between the two active ingredients listed in Tables 1 and 2.
How long is it used?
Children 4-11 years
Ask a healthcare professional for use beyond 1 week [Source note 14].
Adolescents 12-17 years; Adults 18 years and older
Ask a healthcare professional for use beyond 2 weeks [Source note 15].
Warnings and precautions
All products
Ask a healthcare professional if symptoms persist or worsen.
Ask a healthcare professional before use if you are pregnant or breastfeeding [Source note 16].
Essential oil and Tincture
Ask a health care practitioner before use if you are taking any medications including birth control pills or hormone therapy or other health products [Source note 17].
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 18].
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Storage
Must be established in accordance with the requirements described in the supplement Regulations.
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.