Monograph: Rutin

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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: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2018-07-31

NHPID name

Rutin ( O'Neil et al. 2012 )

Proper name(s)

Common name(s)

Source material

Route Of administration

Oral

Dosage form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets. This monograph is not intended to include foods or 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:

Dose(s):

1 Day per day

Duration of use

For products providing  Doses greater than or equal to 250 Milligrams per day : Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 6 weeks.  (Boyle et al. 2000)

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 prior to use if pregnant or breastfeeding.  (PDR 2008) Contraindication(s): No statement is required 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.

Storage conditions

Store in a light-resistant container (Ph.Eur. 2013).

Specifications

References cited

References reviewed