Monograph: Chamomile, Roman

Help on accessing alternative formats, such as Portable document format (PDF), Microsoft word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2018-10-30

NHPID name

Chamaemelum nobile ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Chamaemelum nobile ( USDA 2008 )

Common name(s)

Source material

Flower ( Wichtl 2004 , Bradley 1992 )

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

(Traditionally) used in Herbal Medicine to help relieve mild digestive disturbances (such as dyspepsia, nausea, flatulence).  (Wichtl 2004, Mills and Bone 2000, Bradley 1992, BHP 1983, Ellingwood 1983[1919], Felter 1983[1922])

Dose(s)

Adults:

Dose(s):

1 Day per day

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/health care provider/health care professional/doctor/physician if symptoms persist or worsen. Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.  (Brinker 2001, Mills and Bone 2000, Blumenthal et al. 1998)

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

References cited

References reviewed

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

Dried flower:

Infusion:

Fluid extract:

Tincture:

0.6-1g dried equivalent, three times per day (1:5, 1-5 ml) (Bradley 1992)