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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.



December 18, 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

Ocimum tenuiflorum

  • Holy basil
  • Rama tulsi
  • Sacred basil
  • Tulsi

Ocimum tenuiflorum



References: Proper name: USDA 2018; McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000, API 1999; Source material: API 1999, Agrawal et al. 1996.

Route of Administration


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 for the specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Ayurveda (as an expectorant and/or demulcent) to help relieve cough (Kasa) and colds and respiratory mucus buildup (catarrh) (Premila 2006; Paranjpe 2005; Sudarshan 2005; Mishra 2004; Williamson 2002; Kapoor 2001; Gogte 2000; API 1999; Jain 1991).


Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".



Adults 18 years and older


Methods of preparation: Dry, Powder, Non-Standardised Ethanolic Extracts (Dry extract, Tincture, Fluid extract)


Not to exceed 3 grams of dried leaf, per day (API 1999).

Ayurveda; Adaptogen

2 - 3 grams of dried leaf, per day (API 1999).

Methods of preparation: Non-Standardised Aqueous Extracts (Dry extract, Decoction, Infusion)


Not to exceed 28 grams of dried leaf, per day (Williamson 2002; Kapoor 2001).


7 - 28 grams of dried leaf, per day (Williamson 2002; Kapoor 2001).


4.2 - 28 grams of dried leaf, per day (Winston and Maimes 2007; Williamson 2002; Kapoor 2001).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

All products

Relief of cough/cold/respiratory mucus buildup; Digestive aid; Adaptogen

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


Do not use this product if you are pregnant (Prakash et al. 2005; Ahmed et al. 2002; WHO 2002; Wohlmuth 2002; Kapoor 2001).

Known adverse reaction(s)

No statement required.

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.


References Cited

References Reviewed