yellowing of the eyes and/or skin, dark urine, abdominal pain, jaundice) or symptoms of low estrogen (Reed et al. Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if you develop liver-related symptoms (e.g.Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are attempting to conceive (Bennetts et al.Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking medications or natural health products (Brinker 2018 Linus Pauling Institute 2008 Reed et al.Products providing 6 milligrams or more of DIM, per day Products making healthy estrogen balance/metabolism claimĬonsult a health care practitioner/health care provider/health care professional/doctor/physician prior to use to exclude the diagnosis of a serious cause of hormonal imbalance (UpToDate 2014).Ĭonsult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen. Risk Information Caution(s) and warning(s) Healthy Estrogen Metabolism Recurrent Breast PainĦ0 - 200 milligrams of DIM, per day (Laidlaw et al. Not to exceed 200 milligrams of DIM, per day (Laidlaw et al. The singular should be used when the product only contains one medicinal ingredient associated with this claim. Note: If 3,3'-Diindolylmethane (DIM) is combined with another medicinal ingredient with antioxidant properties at Class II and III, there is an option to use the antioxidant statements in plural.
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Source of/Provides (an) antioxidant(s) that help(s) fight/protect (cell) against/reduce (the oxidative effects of/the oxidative damage caused by/cell damage caused by) free radicals (Fowke et al.Source of/Provides (an) antioxidant(s) (Fowke et al.This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.Īcceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications. References: Proper names: NIH 2014 Common names: NIH 2014 Source information: Pradhan et al. Proper name(s), Common name(s), Source information Proper name(s) Either term or statement may be selected by the applicant.įebruProper name(s), Common name(s), Source information Table 1. The solidus (/) indicates that the terms and/or statements are synonymous.Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.It is not intended to be a comprehensive review of the medicinal ingredient. 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.
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