Monograph: Amla - Phyllanthus emblica

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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: 2018-12-18

NHPID name

Phyllanthus emblica ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Phyllanthus emblica ( USDA 2005 , McGuffin et al. 2000 )

Common name(s)

Source material

Fruit ( API 2001 [1990] , Khory and Katrak 1999[1903] )

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

Directions for use: Take 2 hours before or after taking other medications.

Dose(s):

1 Day per day

Directions for use: Allow at least 6 to 12 hours for laxative effect to occur.

Duration of use

For products providing  not to exceed 14 Grams per day : Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days.

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if laxative effect occurs.

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