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Mono Rosemary - Oral English

This document provides information on the natural health product rosemary (Rosmarinus officinalis) for oral administration. It includes the proper and common names, plant source, route of administration, dosage forms, uses for relieving indigestion and headaches, dosages, subpopulations, cautions and contraindications during pregnancy or breastfeeding.

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Tom Delonge
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69 views4 pages

Mono Rosemary - Oral English

This document provides information on the natural health product rosemary (Rosmarinus officinalis) for oral administration. It includes the proper and common names, plant source, route of administration, dosage forms, uses for relieving indigestion and headaches, dosages, subpopulations, cautions and contraindications during pregnancy or breastfeeding.

Uploaded by

Tom Delonge
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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NATURAL HEALTH PRODUCT

ROSEMARY – ROSMARINUS OFFICINALIS


Oral

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)

Table 1. Proper name(s), Common name(s), Source material(s)


Source material(s)
Proper name(s) Common name(s)
Proper name(s) Part(s) Preparation(s)
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.

Rosemary - Rosmarinus officinalis - Oral Page 2 of 4


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.

Rosemary - Rosmarinus officinalis - Oral Page 3 of 4


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.

Rosemary - Rosmarinus officinalis - Oral Page 4 of 4

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