ROSEMARY - ROSMARINUS OFFICINALIS - Oral
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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 statements are synonymous. Either term or statement may be selected by the applicant.
Date
December 18, 2018
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation | ||
Rosmarinus officinalis |
Rosemary |
Rosmarinus officinalis |
Leaf |
Dried |
References: Proper name: USDA 2018; Common name: McGuffin et al. 2000; Source material: Blumenthal et al. 2000.
Route of Administration
Oral (ESCOP 2003)
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
- (Traditionally) used in Herbal Medicine to help relieve flatulent indigestion (carminative) (Barnes et al. 2007; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).
- (Traditionally) used in Herbal Medicine to help ease (gastric) headaches (Barnes et al. 2007; Bradley 2006; Mills and Bone 2005; Hoffmann 2003; Blumenthal et al. 2000; Tilgner 1999; Grieve 1971).
The following combined use(s) or purpose(s) is/are also acceptable:
(Traditionally) used in Herbal Medicine to help ease (gastric) headaches and relieve flatulent indigestion (carminative) (Barnes et al. 2007; Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Tilgner 1999; Grieve 1971).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardised Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
0.6 - 12 grams of dried leaf, per day (Barnes et al. 2007; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; BHP 1983).
Methods of preparation: Non-Standardised Aqueous Extracts (Dry extract, Decoction, Infusion)
2 - 12 grams of dried leaf, per day (Mills and Bone 2005; ESCOP 2003; Blumenthal et al. 2000; BHP 1983).
Direction(s) for use
No statement required.
Duration(s) of Use
No statement required.
Risk Information
Caution(s) and warning(s)
Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Contraindication(s)
Do not use this product if you are pregnant or breastfeeding (Brinker 2010; Barnes et al. 2007; Blumenthal et al. 2000; McGuffin et al. 1997)
Known adverse reaction(s)
No statement required.
Non-medicinal ingredients
Must be chosen from the current Natural Health Product Ingredient Database (NHPID) and must meet the limitations outlined in the database.
Storage conditions
No statement required.
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.
References Cited
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press; 2007.
- BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
- Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
- 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. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Grieve M. A Modern Herbal, Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
- Hoffmann D. Medical Herbalism. 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.
- 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. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
- Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.
- USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Rosmarinus officinalis L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 October 1]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=32207
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
- Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.