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Drugs and Health Products

Monograph: Free Plant Sterols

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Date: 2019-06-02

NHPID Name

Free plant sterols (Niittynen et al. 2008)

Proper Name(s)

Free plant sterols ( Unavailable )

Common Name(s)

Free plant sterols ( Unavailable )

Source Material


Route Of Administration

Oral ( FDA 2000 , Lau et al. 2005 , Thomsen et al. 2004 )

Dosage Form(s)

The acceptable pharmaceutical dosage forms suited to oral administration include, but are not limited to, chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons. This labelling standard 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 with food. (FDA 2009, Lau et al. 2005, Thomsen et al. 2004, FDA 2000)

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 prior to use if you are pregnant or breastfeeding.

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.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).