Marshmallow - ALTHAEA OFFICINALIS - Root

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Monograph: Marshmallow - ALTHAEA OFFICINALIS - Root (English) (PDF Version - 36 K)


This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

July 31, 2018

Proper name(s), Common name(s), Source ingredient(s)

Table 1. Proper name(s), Common name(s), Source ingredient(s)
Proper name(s) Common name(s) Source ingredient(s)
Source material(s) Part(s) Preparation(s)
Althaea officinalis
  • Marshmallow
  • White-mallow
    		•  Althaea officinalis Root Dried

    References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000, Wiersema and León 1999; Source ingredient: Blumenthal et al. 2000, 1998, BHP 1983, Grieve 1971.

    Route of administration

    Oral

    Dosage form(s)

    This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs 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; EMEA/CHMP 2006).

    Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

    Use(s) or Purpose(s)

    Note
    Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

    Dose(s)

    Subpopulation(s)

    As specified below.

    Quantity(ies)

    Relief of the irritation of the oral and pharyngeal mucosa & dry cough

    Methods of preparation: Dry, Powdered, Infusion, cold water

    Table 2. Dose information for marshmallow root presented as dose per day and per single dose
    Subpopulation(s) Dried root(g/day) Dried root (g/single dose)
    Minimum Maximum Maximum
    Children
    3-5 years 1.5g1 3g11g
    6-11 years 1.5g1 4.5g11.5g
    Adolescents
    12-17 years 1.5g2 15g25g
    Adults 18 years and above 1.5g215g25g

    1EMEA 2009
    2EMEA 2009; 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) (Blumenthal et al. 2000; BHC 1992)


    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 (EMEA 2009; BHC 2006; Mills and Bone 2005; BHP 1983).

    Note: Dried or powdered root should be prepared as a cold infusion (see direction for use).

    Direction(s) for use

    All Products

    Take a few hours before or after taking other medications or natural health products (EMEA 2009; BHC 2006; Mills and Bone 2005; Blumenthal et al. 2000).


    Dried root

    Add dried root to 150 ml cold water and let steep for 30 minutes. Stir frequently. Strain and warm (if desired) before drinking (Blumenthal 2000; BHC 1996).


    Powdered root

    Add powdered dried root to 150 milliliters of cold water and let steep for 30 minutes. Stir frequently. Strain and warm (if desired) before drinking (Blumenthal 2000; BHC 1996).

    Duration(s) of use

    No statement required.

    Risk information

    Caution(s) and warning(s)

    Contraindication(s)

    No statement required.

    Known adverse reaction(s)

    No statement required.

    Non-medicinal ingredients

    Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

    Storage conditions

    No statement required.

    Specifications

    References cited

    References reviewed