ELDER – SAMBUCUS

Monograph: ELDER - SAMBUCUS (PDF Version - 104 KB)

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 label at the applicant's discretion.
  • The solidus (/) indicates that either term and/or statement may be selected on the label.

Date

December 19, 2025

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

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s) Preparation(s)
Sambucus nigra subsp. nigra
  • Black elder
  • European elder
 Sambucus nigra subsp. nigra
  • Flower
  • Fruit
 Dry
Sambucus nigra subsp. canadensis
  • American elder
  • Canadian elder
  • Sweet elder
 Sambucus nigra subsp. canadensis

References: Proper names: USDA 2024; Gardner and McGuffin 2013; Common names: NHPID 2024; Source information: EMA 2018; Godfrey and Saunders 2010; Hoffman 2003.

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 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/ liquid preparations (Giacoia et al. 2008; EMA/CHMP 2006).
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: Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Adults 18 years and older

Flower

  • (Traditionally) used in Herbal Medicine (as a diaphoretic) to promote sweating to help relieve fever (in cases of common colds, flus) (Godfrey and Saunders 2010; Bone 2003; Hoffman 2003; WHO 2002; BHC 1992; BHP 1983; Grieve 1931; Sayre 1917; Felter and Lloyd 1898).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; BHP 1983; Grieve 1931).
  • Used in Herbal Medicine to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003).
  • (Traditionally) used in Herbal Medicine as a diuretic (Winston and Kuhn 2008; Barnes et al. 2007; Williamson 2003; BHC 1992; Felter 1922; Culbreth 1927; Fyfe 1903).
  • (Traditionally) used in Herbal Medicine (as an alterative) to help remove accumulated waste products via the kidneys, skin and mucus membranes (Williamson 2003; Tilgner 1999; Felter 1922; Culbreth 1921; Fyfe 1903; Felter and Lloyd 1898).

Fruit

  • (Traditionally) used in Herbal Medicine (as a diaphoretic) to promote sweating to help relieve fever (in cases of common colds, flus) (Winston and Kuhn 2008; Hoffman 2003; Shook 1992; Grieve 1931; Remington et al. 1918).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Winston and Kuhn 2008; Hoffman 2003; Tillotson 2001; Shook 1992).
  • (Traditionally) used in Herbal Medicine to help relieve joint pain associated with conditions such as arthritis (Godfrey and Saunders 2010; Hoffman 2003; Tilgner 1999; Grieve 1931; Remington et al. 1918).
  • (Traditionally) used in Herbal Medicine as a diuretic (Hoffman 2003; Shook 1992; Fyfe 1903).
  • (Traditionally) used in Herbal Medicine (as an alterative) to help remove accumulated waste products via the kidneys, skin and mucus membranes (Tilgner 1999; Shook 1992; Grieve 1931; Remington et al. 1918; Fyfe 1903).
  • Source of antioxidants/Provides antioxidants (Youdim et al. 2004; Abuja et al. 1998).
  • Source of antioxidants/Provides antioxidants that help fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals (Youdim et al. 2004; Abuja et al. 1998).

Children 2-11 years and Adolescents 12-17 years

Flower and/or Fruit

  • (Traditionally) used in Herbal Medicine (as a diaphoretic) to promote sweating to help relieve fever (in cases of common colds, flus) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Bone 2003; Hoffman 2003; WHO 2002; Shook 1992; BHC 1992; BHP 1983; Grieve 1931; Remington et al. 1918; Sayre 1917; Felter et Lloyd 1898).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; Tillotson 2001; Shook 1992; BHP 1983; Grieve 1931).

Flower

Used in Herbal Medicine to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003).

Notes

  • The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g., Used in Herbal Medicine to help relieve symptoms of colds and flus and to help relieve nasal congestion and discharge associated with sinusitis, hay fever).
  • 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 medicinal 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., Black elder is traditionally used in Herbal Medicine as a diuretic).
    • When ALL of the medicinal 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.

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

Flower

Methods of preparation: Dry, Powdered, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

Table 2. Dose information (grams) per day for dried flower of black elder or American elder or the total of black elder and American elder
Use(s) or purpose(s) Subpopulation(s)1,2 Dried flower (g/day)
Minimum Maximum
  • Diaphoretic
  • Sinusitis, hay fever
  • Symptoms of colds and flus
 Children 2-4 years 0.25 g 2.5 g
5-9 years 0.375 g 3.75 g
Children 10-11 years 0.75 g 7.5 g
Adolescents 12-13 years 0.75 g 7.5 g
Adolescents 14-17 years 1.5 g 15 g
  • Alterative
  • Diaphoretic
  • Diuretic
  • Sinusitis, hay fever
  • Symptoms of colds and flus
 Adults 18 years and older 1.5 g 15 g

1Children and adolescent doses were calculated as a proportion of the adult dose (JC 2023). The use of Elder spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.
2Adult dose supported by the following references: Winston and Kuhn 2008; Bone 2003; WHO 2002; BHC 1992; Fyfe 1903.

Method of preparation: Infusion

Table 3. Dose information (grams) per day for dried flower of black elder or American elder or the total of black elder and American elder
Use(s) or purpose(s) Subpopulation(s)1,2 Dried flower (g/day)
Minimum Maximum
  • Diaphoretic
  • Sinusitis, hay fever
  • Symptoms of colds and flus
 Children 2-4 years 1 g 2.5 g
5-9 years 1.5 g 3.75 g
Children 10-11 years 3 g 7.5 g
Adolescents 12-13 years 3 g 7.5 g
Adolescents 14-17 years 6 g 15 g
  • Alterative
  • Diaphoretic
  • Diuretic
  • Sinusitis, hay fever
  • Symptoms of colds and flus
 Adults 18 years and older 6 g 15 g

1Children and adolescent doses were calculated as a proportion of the adult dose (JC 2023). The use of Elder spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.
2Adult dose supported by the following references: Hoffman 2003 Williamson 2003; WHO 2002; BHC 1992.

Fruit

Methods of preparation: Dry, Powdered, Non-Standardized Extracts (Dry extract*, Tincture, Fluid extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)

Table 4. Dose information (grams) per day for dried fruit of black elder or American elder or the total of black elder and American elder
Use(s) or purpose(s) Subpopulation(s)1,2 Dried fruit(g/day)
Minimum Maximum
  • Diaphoretic
  • Symptoms of colds and flus
 Children 2-4 years 0.217 g 3 g
5-9 years 0.325 g 4.5 g
Children 10-11 years 0.65 g 9 g
Adolescents 12-13 years 0.65 g 9 g
Adolescents 14-17 years 1.3 g 18 g
  • Alterative
  • Diaphoretic
  • Diuretic
  • Sinusitis, hay fever
  • Symptoms of colds and flus
 Adults 18 years and older 1.5 g 15 g
Antioxidants Adults 18 years and Older - 18 g

1Children and adolescent doses were calculated as a proportion of the adult dose (JC 2023). The use of Sambucus spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.
2Adult dose supported by the following references: Winston and Kuhn 2008; Tillotson 2001; Fyfe 1903.

*Note: Solvents allowed for the method of preparation “Non-standardized extracts (Dry extract)” as part of this monograph are ethanol and/or water only.

Direction(s) for use

No statement required.

Duration(s) of use

Diuretic

For occasional use only (APhA 2002; CPhA 2002).

All other products

No statement required.

Risk information

Caution(s) and warning(s)

All products

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding.

Diaphoretic; Symptoms of colds, flus; Sinusitis, hay-fever; Joint pain

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

All products

Stop use if hypersensitivity/allergy occur (Forster-Waldl et al. 2003).

All products except those making a diuretic claim

When using this product diuretic effect may occur (Bradley 1992; Winston and Kuhn 2008; Barnes et al. 2007; Hoffman 2003).

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

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.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References cited

  • Abuja PM, Murkovic M., Pfannhauser W. Antioxidant and Prooxidant Activities of Elderberry (Sambucus nigra) Extract in Low-Density Lipoprotein Oxidation. Journal of Agricultural and Food Chemistry 1998;46(10):4091-4096.
  • APhA 2002: Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • Artz S.A., Paes I.C., Faloon W.W. Hypokalemia-induced hepatic coma in cirrhosis. Occurrence despite neomycin therapy. Gastroenterology 1966;51(6):1046.
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  • BHC 1992: Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs—Companion to Volume 1 of the British Herbal Pharmaocopeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
  • BHP 1983: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1983.
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  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. Toronto (ON): McGraw-Hill; 2001.
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  • CPhA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
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  • EMA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. Adopted September 2006. EMA/CHMP/PEG/194810/2005. [Accessed on 2024 February 29]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf
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References reviewed

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