CALIFORNIA POPPY - ESCHSCHOLZIA CALIFORNICA

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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

October 30, 2018

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

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

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)	Preparation
Eschscholzia californica	California poppy	Eschscholzia californica	Herb top	Dried

References: Proper name: USDA 2018; Common name: McGuffin et al. 2000; Source material: Mills and Bone 2005, Hoffmann 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 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 restlessness and/or nervousness (calmative) (Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983).
• Traditionally used in Herbal Medicine as a sleep aid (Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983).
• Traditionally used in Herbal Medicine as an analgesic (Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983).

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 Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

0.2-3 grams of dried herb tops, per day (Mills and Bone 2005; Hoffmann 2003)

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Sleep aid

• Consult a health care practitioner/health care provider/health care professional/doctor/ physician if sleeplessness persists continuously for more than 4 weeks (chronic insomnia) (Berardi et al. 2002; Dipiro et al. 2002).

All uses (except sleep aid)

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

All uses

• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are breastfeeding (Brinker 2010; Mills and Bone 2005).
• Avoid taking with alcohol or products that cause drowsiness and/or with analgesic properties (Brinker 2010; Mills and Bone 2005; Hoffmann 2003).

Contraindication(s)

Do not use this product if you are pregnant (Brinker 2010; Blumenthal et al. 2000).

Known adverse reaction(s)

Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness (Mills and Bone 2005; Felter and Lloyd 1983).

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

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

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.

Brinker F. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.

Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: a pathophysiologic approach, 5^th edition. New York (NY): The McGraw-Hill Companies, Inc.; 2002.

Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18^th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

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.

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.

USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Eschscholzia californica Cham. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 August 7]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References Reviewed

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

Moore M. Medicinal Plants of the Pacific West. Santa Fe (NM): Red Crane Books, Inc.; 1993.

Sayre LE. A Manual of Organic Materia Medica and Pharmacognosy. Philadelphia (PA): P. Blakiston's Son & Co.; 1917.