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Drugs and Health Products

Monograph: Black Horehound

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Date: 2008-02-14

NHPID Name

Ballota nigra (USDA 2008)

Proper Name(s)

Ballota nigra L. (Lamiaceae) ( USDA 2008 )

Common Name(s)

Source Material

Herb top ( BHP 1983 )

Route Of Administration

Oral

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.3 - 12 Grams per day, dried herb tops

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are breastfeeding

Contraindication(s):
Do not use if you are pregnant  (Brinker 2001)

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database 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 NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Black Horehound Monographs published in the European or British Pharmacopoeias.

References cited

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.

References reviewed

McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Dried leaf:

0.5-4 g, 1-3 times per day (Bradley 2006)

Infusion:

2-4 g dried aerial parts, 3 times per day (BHP 1983)

Directions for use:

Pour 250 ml (1 cup) of boiling water over dried aerial parts and infuse for 10 to 15 minutes (Hoffmann 2003).
2 g = 1 tsp (Hoffman 2003)

Fluidextract:

1-3 g dried equivalent, 3 times per day
(1:1, 25% ethanol, 1-3 ml) (Bradley 2006)

Tincture:

  • 0.2-0.4 g dried equivalent, 3 times per day
    (1:5, 25% ethanol, 1-2 ml) (Hoffmann 2003)
  • 0.1-0.2 g dried equivalent, 3 times per day
    (1:10, 45% ethanol, 1-2 ml) (BHP 1983)