BILBERRY - VACCINIUM MYRTILLUS - Buccal

Date

January 30, 2026

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

References: Proper name: USDA 2024; Common names: Gardner and McGuffin 2013; Source information: Blumenthal et al. 2000.

Route of Administration

Buccal (Blumenthal et al. 2000)

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

The following dosage forms are acceptable when used according to the requirements indicated in this monograph (allow for direct contact between the affected tissue and the medicinal ingredient): Gargle; Loose; Mouthwash; Powder.

Use(s) or Purpose(s)

Used in Herbal Medicine to help relieve mild inflammations of the mucous membranes of the mouth and/or throat (EMA 2015; ESCOP 2003; Blumenthal et al. 2000).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Loose/Powder dosage forms

Methods of preparation: Dry, Powdered

5 - 20 grams of dried fruits (EMA 2015; Blumenthal et al. 2000).

Note: Powdered and dried fruits must be prepared as a decoction by consumers prior to use (see direction for use).

Gargle/Mouthwash dosage forms

Methods of preparation: Decoction, Decoction concentrate

5 - 20 grams of dried fruits (EMA 2015; Blumenthal et al. 2000).

Direction(s) for use

Loose/Powder dosage forms

• Place [insert volume to be measured by consumer in order to obtain 5 to 20 grams dried fruits, e.g., 1 teaspoon] of dried fruits in [insert the volume of water^*, e.g. ½ cup (125 mL), 1 cup (250 mL)] of cold water. Bring to a boil for approximately 10 minutes and strain. Let cool (ESCOP 2003; Blumenthal et al. 2000).
• Use 1 tablespoon (15 mL) as a mouthwash/gargle as needed (EMA 2015; ESCOP 2003; Blumenthal et al. 2000).
• Do not swallow (Berardi et al. 2002).

*Note: The volume of water should be about 10 times the amount of dried fruits (e.g., 20 g of dried fruits in 200 mL of water) (EMA 2015).

Gargle/Mouthwash dosage forms

• Use 1 tablespoon (15 mL) as a mouthwash/gargle as needed.
• Do not swallow (Berardi et al. 2002).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

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)

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

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.

References cited

• 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, 13^th edition. Washington (DC): American Pharmaceutical Association; 2002.
• Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
• EMA 2015. European Medicines Agency. European Union herbal monograph on Vaccinium myrtillus L., fructus siccus. London (UK): EMA Committee on Herbal Medicinal Products (HMPC), May 15 2015. [Accessed 2025 December 22]. Available from: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-vaccinium-myrtillus-l-fructus-siccus_en.pdf
• ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
• Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. 2^nd edition. Boca Raton (FL): Taylor and Francis Group; 2013.
• USDA 2024: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2024 May 15]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch

References reviewed

• Brinker F. Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• Canter PH, Ernst E. Anthocyanosides of Vaccinium myritillus (bilberry) for night vision - a systematic review of placebo-controlled trials. Survey of Opthalmology 2004;49(1):38-50.
• Jang YP, Zhou J, Nakanishi K, Sparrow JR. Anthocyanins protect against A2E photooxidation and membrane permeabilization in retinal pigment epithelial cells. Photochemistry and Photobiology 2005;81(3):529-536.
• Lee J, Lee HK, Kim CY, Hong YJ, Choe CM, You TW, Seong GJ. Purified high-dose anthocyanoside oligomer administration improves nocturnal vision and clinical symptoms in myopia subjects. British Journal of Nutrition 2005;93:895-899.
• Levy Y, Glovinski Y. The effect of anthocyanosides on night vision. Eye 1998;12:967-969.
• Muth ER, Laurent JM, Jasper P. The effect of bilberry nutritional supplementation on night vision acuity and contrast sensitivity. Alternative Medicine Review 2000;5(2):164-173.
• Sparrow JR, Vollmer-Snarr HR, Zhou J, Jang PY, Jockusch. A2E-epoxides damage DNA in retinal pigment epithelial cells. Journal of Biological Chemistry 2003;278(20):18207-18213.
• Steigwalt RD Jr, Gianni B, Paolo M, Bombardelli E, Burki C, Schönlau F. Effects of Mirtogenol® on ocular blood flow and intraocular hypertension in asymptomatic subjects. Molecular Vision 2008;14:1288-1292.
• Zadok D, Levy Y, Glovinski Y. The effect of anthocyanosides in multiple oral dose on night vision. Eye 1999;13:734-736.

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