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Marshmallow - ALTHAEA OFFICINALIS - Root

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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
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 18, 2017

Proper name(s)

Althaea officinalis L. (Malvaceae) (USDA 2013; McGuffin et al. 2000)

Common name(s)

  • Marshmallow (USDA 2013; McGuffin et al. 2000)
  • White-mallow (USDA 2013; Wiersema and León 1999)

Source material(s)

Root (Blumenthal et al. 2000, 1998; BHP 1983; Grieve 1971)

Route(s) of administration

Oral

Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g., gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

  • (Traditionally) used in Herbal Medicine (as a demulcent) to relieve the irritation of the oral and pharyngeal mucosa and associated dry cough (Mills and Bone 2005; Wichtl 2004; Hoffman 2003; BHC 1992; BHP 1983; Grieve 1971).
  • (Traditionally) used in Herbal Medicine (as a demulcent) to relieve mild inflammation of the gastro-intestinal mucosa, e.g. gastritis, peptic and duodenal ulceration, enteritis (Mills and Bone 2005; Wichtl 2004; Hoffman 2003; Blumenthal et al. 2000, 1998; Ellingwood 1998 (1919); BHC 1992; BHP 1983; Grieve 1971; Cook 1869).

Dose(s)

Subpopulation(s) and Quantity(ies):

RELIEF OF ORAL AND PHARYNGEAL MUCOSA IRRITATION & DRY COUGH

Cold infusion/Macerate or powder

Subpopulation Dried root (g/day)
Minimum Maximum

Table 1 Footnotes

Table 1 Footnote 1

EMEA 2009

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

EMEA 2009; Mills and Bone 2005; WHO 2002; ESCOP 1996; BHP 1983; Cook 1869

Return to Table 1 footnote2 referrer

Children 3-6 y 1.51 31
6-12 y 1.51 4.51
Adolescents and Adults ≥ 13 y 1.52 152

Tincture

Adults (≥ 18 years): 1-15 g dried root, per day (1:5, in 25% ethanol) (Blumenthal et al. 2000; BHC 1992)

Directions for use

All products

  • Take in 3 divided doses, per day (EMEA 2009; BHC 2006; Blumenthal et al. 2000).
  • Take a few hours before or after taking other medications or natural health products (Mills and Bone 2005; Blumenthal et al. 2000).

Cold infusion/Macerate

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

RELIEF OF GASTROINTESTINAL IRRITATION

Cold infusion/Macerate

Adults (≥ 18 years): 6-15 g dried root, per day (EMEA 2009; BHC 2006; Mills and Bone 2005; BHP 1983).

Directions for use

  • Take in 3 divided doses, per day (EMEA 2009; BHC 2006; Blumenthal et al. 2000).
  • Take a few hours before or after taking other medications or natural health products (Mills and Bone 2005; Blumenthal et al. 2000).
  • Add powder/dried herb to 150 ml cold water and let steep for 30 minutes. Stir frequently. Strain and warm (if desired) before drinking (Blumenthal 2000; BHC 1996).

Duration of use

No statement required.

Risk information

Caution(s) and warning(s)

  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Storage conditions

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.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 1 below.

Table 1: Marshmallow monographs published in the British (BP) and European (Ph.Eur.) pharmacopoeias

Pharmacopoeia Monograph
BP Marshmallow Root
Ph. Eur.

References cited

  • BHC 1992: Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs – Companion Volume 1 of the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
  • BHP 1983: British Herbal Medicine Association's Scientific Committee. British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1983.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications; 2000.
  • Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in Cooperation with Integrative Medicine Communications; 1998.
  • Cook WMH. The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet] Cincinnati (OH): WH Cook; 1869. Reprint version by Medical Herbalism: Journal for the Clinical Practitioner [Accessed 2013 May 21]. Available from: Next link will take you to another Web site http://www.henriettesherbal.com/eclectic/cook/index.html
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1998 [Reprint of 1919 original].
  • EMEA 2009: EMEA/HMPC/98717/2009 Community Herbal Monograph on Althaea officinalis L., Radix. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC); 14 May 2009. [Accessed 2013 May 21] Available from:Next link will take you to another Web site http://www.ema.europa.eu//
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web site Formulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • ESCOP 1996: European Scientific Cooperative of Phytotherapy. Monographs on the Medicinal Uses of Plant Drugs. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 1996.
  • Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
  • Grieve M. A Modern Herbal, Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors.Herbs of Commerce.2nd edition.Silver Spring (MD): American Herbal Products Association; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
  • WHO 2002: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva (CH): World Health Organization; 2002.
  • USDA 2013: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Online Database]. National Germplasm Resources Laboratory, Beltsville (MD). [Althaea officinalis L. Last updated: 23-Aug-1994; Accessed 2013 May 10]. Available from: Next link will take you to another Web site http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.

References reviewed

  • Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. 3rd ed. London (GB): Pharmaceutical Press; 2007.
  • Bartram T. Bartram's Encyclopedia of Herbal Medicine: The definitive guide to the herbal treatment of diseases. London (GB): Robinson Publishing Ltd; 1998.
  • Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drugs—Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
  • Brinker 2010: Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 3rd edition, including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 April 18]. Available from: Next link will take you to another Web site http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brinker F. Herb Contraindications and Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 19]. Available from: Next link will take you to another Web site http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
  • Chandler F, editor. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association; 2000.
  • Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Felter HW, Lloyd JU. King's American Dispensatory. Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Hoffman D. Complete Illustrated Guide to The Holistic Herbal: A safe and practical guide to making and using herbal remedies. London (GB): Element, an imprint of Harper Collins Publishers; 2002.
  • Lust J. The Herb Book: The Complete and Authoritative Guide to More than 500 Herbs. New York (NY): Benedict Lust Publications; 2005.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
  • Mills S, Bone K. Principles and Practice of Phytotherapy, Modern Herbal Medicine. Edinburg: Churchill Livingston; 2000.
  • Natural Health Products Compliance and Enforcement Policy. Ottawa (ON): Health Products and Food Branch. [Date Modified 2010-08-27; Accessed 2012 April 19]. Available from: Next link will take you to another Web site http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/info-prod/prodnatur/complian-conform-pol-eng.pdf
  • Natural Standard. Mashmallow (Althaea officinalis L.) Copyright 2012 [Internet]. [Accessed 2012 April 18]. Available from: Next link will take you to another Web site http://www.naturalstandard.com
  • Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A guide for health-care professionals. London (GB): The Pharmaceutical Press; 1996.
  • Remington JP, Woods HC, editors. The Dispensatory of the United States of America [Internet] 20th edition; 1918. Abridged; botanicals only. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 19]. Available from: Next link will take you to another Web site http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf
  • Weiss RF, Fintelmann V. Herbal Medicine. Second edition, revised and expanded. New York (NY): Thieme; 2000.
  • WHO Food Additives Series: 63; FAO JECFA Monographs 8. Safety evaluation of certain contaminants in food. [Internet]. Geneva (CH): World Health Organization; 2011. [Accessed 2012 April 19]. Available from: Next link will take you to another Web site http://www.inchem.org/documents/jecfa/jecmono/v63je01.pdf
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1998.
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited; 2003.
  • Wren RC, Evans FJ. Potter's New Encyclopedia of Botanical Drugs and Preparations. Essex (GB); Potter's (Herbal Supplies) Limited; 1985 (Reprint of 1907).