What is it used for?
(Used in Herbal Medicine as a) bulk-forming laxative (ESCOP 2003a,b,c; Williamson 2003; FDA 1985).
(Used in Herbal Medicine to) promote(s) bowel movements (by increasing bulk volume and water content) (Sweetman 2007; WHO 2007; ESCOP 2003a,b,c; Bradley 1992; FDA 1985).
(Used in Herbal Medicine to) provide(s) gentle relief of constipation and/or irregularity (EMA 2013a,b,c; Pray 2006; ESCOP 2003a,b,c; Blumenthal et al. 2000; Gennaro 2000; Bradley 1992; FDA 1985).
Note: The above uses can be combined on the product label if from the same non-traditional system of medicine (e.g. Used in Herbal Medicine as a bulk-forming laxative for gentle relief of constipation and/or irregularity).
What this guide covers
Text in parentheses is additional optional information which can be included on the product documentation and product labels 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.
Quantities
Methods of preparation: Dry, Powdered
| Subpopulation(s) | Subpopulation(s) | Seed (grams) / Minimum/day | Seed (grams) / Maximum/day | Seed (grams) / Maximum/single dose³ |
|---|---|---|---|---|
| Children¹ | 6-11 years | 1.25 g | 25 g | 8 g |
| Adolescents² | 12 years | 1.25 g | 25 g | 8 g |
| Adolescents² | 13-17 years | 2.5 g | 40 g | 13 g |
| Adults² | 18 years and older | 2.5 g | 40 g | 13 g |
¹ EMA 2013a,b; ESCOP 2003a,b; WHO 1999; FDA 1985. ²EMA 2013a,b; ESCOP 2003a,b; Williamson 2003; Blumenthal et al. 2000a,b; WHO 1999; FDA 1985. ³Note: The maximum single dose (13 g) for adults and adolescents 13 years and older is based on the consensus of evidence from several references. The maximum single dose (8 g) for children and adolescents up to 12 years was calculated as a fraction of the maximum adult doses.
| Subpopulation(s) | Subpopulation(s) | Husk (grams) / Minimum/day | Husk (grams) / Maximum/day | Husk (grams) / Maximum/single dose³ |
|---|---|---|---|---|
| Children¹ | 6-11 years | 1.25 g | 15 g | 4 g |
| Adolescents² | 12 years | 1.25 g | 15 g | 4 g |
| Adolescents² | 13-17 years | 2.5 g | 30 g | 8 g |
| Adults² | 18 years and older | 2.5 g | 30 g | 8 g |
¹EMA 2013c; ESCOP 2003c; FDA 1985. ²EMA 2013c; ESCOP 2003c; Williamson 2003; Blumenthal et al. 2000c; Bradley 1992; FDA 1985. ³Note: The maximum single dose (8 g) for adults and adolescents 13 years and older is based on the consensus of evidence from several references. The maximum single dose (4 g) for children and adolescents up to 12 years was calculated as a fraction of the maximum adult doses.
How is it used?
For each dose, drink at least 250 ml of liquid (EMA 2013a,b,c).
Mix well with liquid and drink immediately.
Maintain adequate fluid intake (EMA 2013a,b,c).
Take a few hours before or after taking other medications or health products (EMA 2013a,b,c).
Effects observed 12-24 hours after first dose, and may take 2-3 days (EMA 2013a,b,c).
Optional
Take during the day (not immediately prior to bedtime) (EMA 2013a,b,c).
Optional (for products with a dosage range)
Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
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 worsen or if laxative effect does not occur within 7 days [Source note 2].
Ask a healthcare professional immediately if you experience chest pain, vomiting, or difficulty swallowing or breathing after taking this product (EMA 2013a,b,c; ESCOP 2003a,b,c).
Ask a healthcare professional before use if you have diabetes or a lazy bowel (UpToDate 2024; EMA 2013a,b,c).
When should it be avoided?
Do not use if you have difficulty swallowing (EMA 2013a,b,c).
Do not use if you have fever or any undiagnosed gastrointestinal trouble (EMA 2013a,b,c).
Possible side effects
Stop use if hypersensitivity/allergy occurs (EMA 2013a,b,c).
When using this product you may experience temporary gas and bloating (EMA 2013a,b,c).
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
Conditions for combined preparations
When the active ingredients listed in Table 1 are combined:
the total quantities of psyllium seed per single dose and per day must not exceed the maximum quantities listed in Table 2.
the total quantities of psyllium husk per single dose and per day must not exceed the maximum quantities listed in Table 3.
if psyllium seed and husk are combined, the total quantities per single dose and per day must not exceed the lowest maximum quantities which are the husk quantities in Table 3.
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) |
|---|---|---|---|---|
| Plantago afra |
| Plantago afra | Seed | Dry |
| Plantago arenaria |
| Plantago arenaria |
| Dry |
| Plantago ovata |
| Plantago ovata |
| Dry |
References: Proper names: USDA 2024; Common names: EMA 2013a,b,c; Gardner and McGuffin 2013; ESCOP 2003b,c; Bradley 1992; Source information: EMA 2013a; ESCOP 2003a.
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
- July 26, 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.