What is it used for?
(Traditionally) used in Herbal Medicine (as a demulcent) to relieve the irritation of the oral and pharyngeal mucosa and associated dry cough [Source note 2].
(Traditionally) used in Herbal Medicine (as a demulcent) to relieve mild inflammation of the gastro-intestinal mucosa (e.g., gastritis) (Mills and Bone 2005; Wichtl 2004; Hoffman 2003; Blumenthal et al. 2000, 1998; Ellingwood 1998; BHC 1992; BHP 1983; Grieve 1971; Cook 1869).
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 relieve mild inflammation of the gastro-intestinal mucosa, the irritation of the oral and pharyngeal mucosa and associated dry cough).
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., Marshmallow is traditionally used in Herbal Medicine to relieve mild inflammation of the gastro-intestinal mucosa).
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 label at the applicant's discretion.
Who does this guide cover?
As specified below.
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 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:
Quantities
Relief of the irritation of the oral and pharyngeal mucosa & dry cough
Methods of preparation: Dry, Powdered, Infusion, cold water
| Subpopulation(s) | Subpopulation(s) | Dried root(g/day) / Minimum | Dried root(g/day) / Maximum | Dried root (g/single dose) / Maximum | Dried root (g/single dose) |
|---|---|---|---|---|---|
| Children | |||||
| Children | 3-5 years | 1.5 g | 3 g | 1 g | |
| Children | 6-11 years | 1.5 g | 4.5 g | 1.5 g | |
| Adolescents | |||||
| Adolescents | 12-17 years | 1.5 g | 15 g | 5 g | |
| Adults | 18 years and above | 1.5 g | 15 g | 5 g |
References: Children: EMA 2016; Adolescents and adults: EMA 2016; Mills and Bone 2005; WHO 2002; ESCOP 1996; BHP 1983; Cook 1869
Note: Dried or powdered root should be prepared as a cold infusion (see direction for use).
Method of preparation: Tincture
Adults 18 years and older
1 – 15 grams dried root, per day; Not to exceed 5 grams per single dose (1:5, in 25% ethanol) [Source note 4]
Relief of mild inflammation of the gastro-intestinal mucosa
Methods of preparation: Dry, Powdered, Infusion, cold water
Adults 18 years and older
6 – 15 grams dried root, per day; Not to exceed 5 grams per single dose [Source note 5].
Note: Dried or powdered root should be prepared as a cold infusion (see direction for use).
How is it used?
All Products
Take a few hours before or after taking other medications or health products [Source note 6].
Dried/powdered root
Add dried/powdered root to 150 milliliters of cold water and let steep for 30 minutes. Stir frequently. Strain and warm (if desired) before drinking [Source note 7].
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
Ask a healthcare professional if symptoms persist or worsen.
Ask a healthcare professional before use if you are pregnant or breastfeeding.
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
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
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) |
|---|---|---|---|---|
| Althaea officinalis |
| Althaea officinalis | Root | Dry |
References: Proper name: USDA 2024; Gardner and McGuffin 2013; Common names: USDA 2024; Gardner and McGuffin 2013; Wiersema and León 1999; Source information: Blumenthal et al. 2000; 1998; BHP 1983; Grieve 1971.
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.