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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
March 12, 2021
Proper name(s) | Common name(s) | Source information | ||||
---|---|---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||||
Group 1: Ingredients with nervine action |
||||||
Anemone pulsatilla |
|
Anemone pulsatilla |
Herb top |
Dried1 |
||
Avena sativa |
|
Avena sativa |
Seed |
Dried |
||
Nepeta cataria |
|
Nepeta cataria |
Herb top |
Dried |
||
Matricaria chamomilla |
|
Matricaria chamomilla |
Flower |
Dried |
||
Panax quinquefolius |
|
Panax quinquefolius |
Root |
Dried |
||
Tilia cordata |
|
Tilia cordata |
Flower |
Dried |
||
Tilia platyphyllos |
|
Tilia platyphyllos |
Flower |
Dried |
||
Tilia x europaea |
|
Tilia x europaea |
Flower |
Dried |
||
Turnera diffusa |
Damiana |
Turnera diffusa |
|
Dried |
||
Withania somnifera |
|
Withania somnifera |
Root |
Dried |
||
Group 2: Ingredients with sedative action |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source material(s) | Part(s) | Preparation(s) | ||||
Eschscholzia californica |
California poppy |
Eschscholzia californica |
Herb top |
Dried |
||
Humulus lupulus |
|
Humulus lupulus |
Strobile |
Dried |
||
Hypericum perforatum |
|
Hypericum perforatum |
Herb top |
Dried |
||
|
|
Griffonia simplicifolia 3 |
Seed |
Dried |
||
Melissa officinalis |
|
Melissa officinalis |
Herb top |
Dried |
||
Passiflora incarnata |
|
Passiflora incarnata |
Herb top |
Dried |
||
Scutellaria lateriflora |
|
Scutellaria lateriflora |
Herb top |
Dried |
||
Stachys officinalis |
|
Stachys officinalis |
Herb top |
Dried |
||
Valeriana officinalis |
|
Valeriana officinalis |
|
Dried |
||
Withania somnifera |
|
Withania somnifera |
Root |
Dried |
||
Group 3: Ingredients with cognitive support action |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source ingredient(s) | Source material(s) | Organism group(s) | Part(s) | Preparation(s) | ||
(2R)-2-(Acetyloxy)-3-carboxy-N,N,N-trimethyl-1-propanaminium inner salt |
Acetylcarnitine |
|
N/A |
N/A |
N/A |
N/A |
Bacopa monnieri |
|
N/A |
Bacopa monnieri |
N/A |
Herb top |
Dried |
|
Choline alfoscerate |
Choline alfoscerate2 |
N/A |
N/A |
N/A |
N/A |
Cod liver oil |
|
N/A |
N/A |
|
Liver |
N/A |
Eleutherococcus senticosus |
|
N/A |
Eleutherococcus senticosus |
N/A |
Root |
Dried |
Fish oil |
Fish oil |
N/A |
N/A |
|
Whole |
N/A |
Ginkgo biloba |
|
N/A |
Ginkgo biloba |
N/A |
Leaf |
N/A |
Panax ginseng |
|
N/A |
Panax ginseng |
N/A |
|
Dried |
Phosphatidylserine |
Phosphatidylserine |
N/A |
Helianthus annuus 3 |
N/A |
Seed |
N/A |
Phosphatidylserine-enriched soy lecithin2 |
N/A |
N/A |
N/A |
N/A |
||
Phosphatidylserine2 |
N/A |
N/A |
N/A |
N/A |
||
Rhodiola rosea |
|
N/A |
Rhodiola rosea |
N/A |
|
Dried |
Schizochytrium spp. |
Schizochytrium Oil |
N/A |
Schizochytrium spp. |
N/A |
Whole |
N/A |
Group 4: Caffeine/Ingredients containing caffeine |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source ingredient(s) | Source material(s) | Part(s) | Preparation(s) | |||
|
Caffeine |
|
N/A |
N/A |
N/A |
|
Ilex paraguariensis |
|
N/A |
Ilex paraguariensis |
Leaf |
Dried |
|
Paullinia cupana |
Guarana |
N/A |
Paullinia cupana |
Seed |
Dried |
|
Group 5: Ingredient with action on cognitive fatigue |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source ingredient(s) | Preparation(s) | |||||
|
|
|
N/A |
|||
Group 6: Ingredients with action on memory |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source material(s) | Part(s) | Preparation(s) | ||||
Bacopa monnieri |
|
Bacopa monnieri |
|
Dried |
||
Withania somnifera |
|
Withania somnifera |
Root |
Dried |
||
Group 7: Ingredients with relaxation action |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source ingredient(s) | Source material(s) | Part(s) | Preparation | |||
4-Aminobutanoic acid |
|
N/A |
Lactobacillus hilgardii3 |
Whole cell for biosynthesis |
N/A |
|
4-Aminobutanoic acid2 |
N/A |
N/A |
N/A |
|||
|
L-Theanine |
N/A |
Camellia sinensis3 |
Leaf |
N/A |
|
L-Theanine2 |
N/A |
N/A |
N/A |
|||
Group 8: Ingredients with adaptogen action |
||||||
Proper name(s) | Common name(s) | Source information | ||||
Source material(s) | Part(s) | Preparation | ||||
Asparagus racemosus |
|
Asparagus racemosus |
Root |
Dried |
||
Astragalus membranaceus |
|
Astragalus membranaceus |
Root |
Dried |
||
Eleutherococcus senticosus |
|
Eleutherococcus senticosus |
|
Dried |
||
Ganoderma lucidum |
|
Ganoderma lucidum |
|
Dried |
||
Glycyrrhiza glabra |
|
Glycyrrhiza glabra |
|
Dried |
||
Ocimum tenuiflorum |
|
Ocimum tenuiflorum |
Leaf |
Dried |
||
Panax ginseng |
|
Panax ginseng |
|
Dried |
||
Panax quinquefolius |
|
Panax quinquefolius |
Root |
Dried |
||
Rhodiola rosea |
|
Rhodiola rosea |
|
Dried |
||
Schisandra chinensis |
|
Schisandra chinensis |
Fruit |
Dried |
||
Tinospora cordifolia |
Guduchi |
Tinospora cordifolia |
Stem |
Dried |
||
Withania somnifera |
|
Withania somnifera |
|
Dried |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Group 1: Bone 2003; Hoffman 2003; Bradley 1992; Williamson et al. 1988; BHP 1983; Remington and Wood 1918; BPC 1911. Group 2: Hoffman 2003; Williamson et al. 1988. Group 3: Yurko-Mauro et al. 2010; Calabrese et al. 2008; Bone 2003; De Jesus Moreno Moreno 2003; Parnetti et al. 2001; Barbagallo et al. 1994; Parnetti et al. 1993; Canal et al. 1991. Group 4: EMA 2013; ESCOP 2009; Bradley 2006; Kennedy et al. 2004; Taylor 2003; Barnes et al. 2002; BHP 1983. Group 6: Bone 2003; API 2001. Group 7: Kanehira et al. 2011; Abdou et al. 2006; Yamakoshi et al. 2006. Group 8: Upton 2012; Winston and Kuhn 2008;Winston and Maimes 2007; WHO 2004; Bone 2003; Hoffman 2003; Thomsen 2002; Williamson 2002; Blumenthal et al. 2000; Upton 1999; WHO 1999; Bradley 1992; BHP 1983.
1Do not use the fresh plant (Bone 2003; Hoffman 2003; Bradley 1992; BHP 1983).
2Synthetic
3Isolate
Oral
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Adults 18 years and older
Refer to Table 2. below.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Group 1: Ingredients with nervine action |
|||
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (nervine/calmative) |
Anemone pulsatilla(Pasqueflower) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.03-0.6 grams dried herb top, per day |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
0.1-0.9 grams dried herb top, per day |
||
Avena sativa(oat) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.6-20 grams dried seed, per day |
|
Matricaria chamomilla(German chamomile) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
1.5-24 grams dried flower, per day |
|
Nepeta cataria(catnip) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
1.2-12 grams dried herb top, per day |
|
Panax quinquefolius(American ginseng) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.5-12 grams dried root, per day |
|
Tilia cordata(Small-leaf linden) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
1.5-12 grams dried flower, per day |
|
Tilia platyphyllos(Large-leaf linden) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
1.5-12 grams dried flower, per day |
|
Tilia x europaea(European Linden) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
1.5-12 grams dried flower, per day |
|
Turnera diffusa(Damiana) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
1.5-4 grams dried leaf/leaf and stem, per day |
|
Traditionally used in Ayurveda to balance aggravated Vata (nervine) |
Withania somnifera(Ashwagandha) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
2-6 grams dried root, per day |
Group 2: Ingredients with calmative sedative action |
|||
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) |
Eschscholzia californica(California poppy) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.2-3 grams dried herb top, per day |
Humulus lupulus(Hops) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.5-6 grams dried strobile, per day |
|
Melissa officinalis(Lemon balm) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.4-13.5 grams dried herb top, per day |
|
Passiflora incarnata(Passionflower) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.25-8 grams dried herb top, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
1-8 grams dried herb top, per day |
||
Scutellaria lateriflora(Skullcap) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.25-12 grams dried herb top, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
3-12 grams dried herb top, per day |
||
Stachys officinalis(Wood betony) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
2-4 grams dried herb top, per day |
|
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) |
Hypericum perforatum(St. John's wort) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
2-12.6 grams dried herb top, per day; Not to exceed 4.2 grams per single dose |
Used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) |
Hypericum perforatum(St. John's wort) |
Standardized Extracts (Dry extract) |
600-1800 milligrams of extract, per day, standardized to 3-6% hyperforin and/or 0.12-0.28% hypericin; Not to exceed 600 milligrams of extract per single dose |
Used as a sleep aid/to help promote sleep |
L-5-Hydroxytryptophan(L-5-HTP) |
Isolate |
100-200 milligrams, per day |
(Traditionally) used in Herbal Medicine to relieve restlessness and/or nervousness (calmative) |
Valeriana officinalis(Valerian) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.3-12 grams dried root/root and rhizome, per day; Not to exceed 3.6 grams per single dose |
Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.3-12 grams of dried root/r root and rhizome, per day; Not to exceed 3.6 grams per single dose and:
|
||
Traditionally used in Ayurveda as a sleep aid and/or to balance aggravated Vata (nervine) |
Withania somnifera (Ashwagandha) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
2-6 grams dried root, per day |
Group 3: Ingredients with cognitive support action |
|||
Helps support cognitive health and/or brain function |
Acetyl-L-Carnitine (Acetylcarnitine) |
N/A |
1.5-4 grams, per day |
Bacopa monnieri (Bacopa) |
Standardized Extracts (Dry extract) |
300 milligrams of extract, per day, standardized to 40-55% bacosides |
|
Cod liver oil |
Standardized fixed oil |
18 years: 19 years and older: |
|
L-alpha-Glycerophosphorylcholine(Choline alfoscerate) |
N/A |
1.2 grams, per day |
|
Fish oil |
Standardized fixed oil |
18 years: |
|
19 years and older: |
|||
Phosphatidylserine |
N/A |
300 milligrams, per day |
|
Schizochytrium oil |
Standardized fixed oil |
200-2,000 milligrams DHA, per day |
|
Used in Herbal Medicine to help improve mental performance after periods of mental exertion |
Eleutherococcus senticosus(Eleuthero) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
0.91-6 grams dried root, per day |
Helps to enhance cognitive function and/or memory in adults |
Ginkgo biloba(Ginkgo) |
Standardized Extracts (Dry extract) |
80-240 milligrams of extract, per day (50:1; quantity crude equivalent 4 - 12 g of dried leaves) and:
|
(Used in Herbal Medicine to) help(s) support cognitive function and/or reduce mental fatigue (in cases of mental stress) |
Panax ginseng(Panax ginseng) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion) |
0.5-9 grams dried root/ rootlet, per day |
Standardized Extracts (Dry extract) |
200-600 milligrams of extract, per day; standardized to 4-7% total ginsenosides; Not to exceed 9 grams of dried root/rootlet, per day |
||
(Used in Herbal Medicine) (to) help(s) support cognitive function (such as mental focus and mental stamina) |
Rhodiola rosea(Rhodiola) |
Tincture |
1.2-1.8 grams of dried root/root and rhizome, per day |
Standardized Extracts (Dry extract) |
144-680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose and:
|
||
Group 4: Caffeine/Ingredients containing caffeine |
|||
Helps (temporarily) to promote alertness and wakefulness, and to enhance cognitive performance |
1,3,7-trimethylxanthine(Caffeine) |
N/A |
100-400 milligrams, per day; and 100-200 milligrams per single dose |
Ilex paraguariensis(Yerba mate) |
Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
Extract corresponding to a maximum Quantity Crude Equivalent of 6 grams dried leaf, per day and not exceeding 150 milligrams caffeine, per day; and providing 100-150 milligrams caffeine per single dose |
|
Paullinia cupana(Guarana) |
Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
Extract corresponding to a maximum Quantity Crude Equivalent of 3 grams dried seed, per day and not exceeding 200 milligrams caffeine per day; and providing 100-200 milligrams caffeine per single dose |
|
Used in Herbal Medicine to help temporarily promote alertness and wakefulness, and to enhance cognitive performance |
Ilex paraguariensis(Yerba mate) |
Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
Extract corresponding to a Quantity Crude Equivalent of 3-6 grams dried leaf, per day and not exceeding 150 milligrams caffeine per day |
Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
Extract corresponding to a Quantity Crude Equivalent of 2-6 grams dried leaf, per day and not exceeding 150 milligrams caffeine per day |
||
Paullinia cupana(Guarana) |
Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
Extract corresponding to a Quantity Crude Equivalent of 1-3 grams dried seed, per day and not exceeding 200 milligrams caffeine per day |
|
Group 5: Ingredient with action on cognitive fatigue |
|||
Helps to decrease cognitive fatigue due to physically stressful situations (e.g. extended wakefulness, exposure to cold, excessive noise) |
L-Tyrosine |
N/A |
10-20 grams, per day; Not to exceed 10 grams per single dose |
Group 6: Ingredients with action on memory |
|||
Traditionally used in Ayurveda for memory enhancement |
Bacopa monnieri (Bacopa) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
1-6.5 grams dried whole plant/herb top, per day |
Withania somnifera(Ashwagandha) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) |
2-6 grams dried root, per day |
|
Helps support memory |
Bacopa monnieri (Bacopa) |
Standardized Extracts (Dry extract) |
300 mg of extract, per day, standardized to 40- 55% bacosides |
Group 7: Ingredients with relaxation action |
|||
Helps to temporarily promote relaxation |
4-Aminobutanoic acid (GABA) |
N/A |
50-3,000 milligrams, per day; Not to exceed 750 milligrams per single dose |
L-Theanine |
N/A |
200-250 milligrams, per day |
|
Group 8: Ingredients with adaptogen action |
|||
Used in Herbal Medicine as an Adaptogen to help increase energy and resistance to stress (e.g. in case of mental and physical fatigue related to stress) |
Asparagus racemosus(Shatavari) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
2-6 grams dried root, per day |
Astragalus membranaceus(Astragalus) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
2-4.8 grams dried root, per day |
|
Eleutherococcus senticosus(Eleuthero) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
1-6 grams dried root/root and rhizome, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
2-3 grams dried root/root and rhizome, per day |
||
Ganoderma lucidum(Reishi) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
1.5-6 grams dried cultured mycelium/ fruiting body/mycelium, per day |
|
Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
1.5-6 grams of dried cultured mycelium/ fruiting body/mycelium, per day and not to exceed 40 % polysaccharides |
||
Decoction, Decoction concentrate |
3-15 grams dried cultured mycelium/ fruiting body/mycelium, per day |
||
Decoction Standardized, Decoction concentrate Standardized |
3-15 grams dried cultured mycelium/ fruiting body/mycelium, per day and not to exceed 40 % polysaccharides |
||
Glycyrrhiza glabra(Licorice) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.6-6 grams dried root/root and stolon, per day |
|
Ocimum tenuiflorum(Holy basil) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
2-3 grams dried leaf, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
4.2-28 grams dried leaf, per day |
||
Panax ginseng |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.5-3 grams dried root/rootlet, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
0.5-2 grams dried root/rootlet, per day |
||
Panax quinquefolius (American ginseng) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
1-3 grams dried root, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
6-9 grams dried root, per day; Not to exceed 3 grams per single dose |
||
Rhodiola rosea(Rhodiola) |
Non-Standardized Ethanolic Extracts (Dry extract) |
144-400 milligrams of dry extract and a Quantity Crude Equivalent (QCE) of 216-2,000 milligrams of dried root/root and rhizome, per day; Not to exceed 200 milligrams of dry extract and a QCE of 1 gram of dried root/root and rhizome, per single dose |
|
Tincture |
1.2-1.8 grams of dried root/root and rhizome, per day |
||
Standardized Extracts (Dry extract) |
144-680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose and:
|
||
Schisandra chinensis (Schisandra) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract |
1.2-6 grams dried fruit, per day |
|
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) |
1.5-6 grams dried fruit, per day |
||
Tinospora cordifolia (Guduchi) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
0.9-3 grams dried stem, per day |
|
Decoction, Decoction concentrate |
20-30 grams dried stem, per day |
||
Withania somnifera (Ashwagandha) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract |
2.5-6.5 grams dried root/whole plant, per day |
|
(Used as an Adaptogen) (to) help(s) (to) temporarily relieve symptoms of stress (such as mental fatigue and sensation of weakness) |
Rhodiola rosea(Rhodiola) |
Non-Standardized Ethanolic Extracts (Dry extract) |
144-400 milligrams of dry extract and a Quantity Crude Equivalent (QCE) of 216-2,000 milligrams of dried root/root and rhizome, per day; Not to exceed 200 milligrams of dry extract and a QCE of 1 gram of dried root/root and rhizome, per single dose |
Tincture |
1.2-1.8 grams of dried root/root and rhizome, per day |
||
Standardized Extracts (Dry extract) |
144-680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose and:
|
||
Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) |
Asparagus racemosus (Shatavari) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) |
3-6 grams dried root, per day |
1References consulted for the uses or purposes: Group 1: Bone 2003; Hoffman 2003; Ellingwood 1983; Felter and Lloyd 1983; Grieve 1971. Group 2: Tobyn et al. 2010; Williamson et al. 1988. Group 3: Morgan and Stevens 2010; Yurko-Mauro et al. 2010; Calabrese et al. 2008; Malaguanera et al. 2008; De Jesus Moreno Moreno 2003; Parnetti et al. 2001; Stough et al. 2001; Thal et al. 2000; Barbagallo et al. 1994; Pettegrewet al. 1994; Parnetti et al. 1993; Sano et al. 1992; Canal et al. 1991; Spagnoli et al. 1991. Group 4: EMA 2013; EMA 2010; ESCOP 2009; Bradley 2006; Christopher et al. 2005; Kennedy al. 2004; Taylor 2003; Barnes et al. 2002; Kamimori et al. 2000; Zwyghuizen- Doorenbos et al. 1990. Group 6: Barbhaiya et al. 2008; Stough et al. 2008; Raghav et al. 2006; Murthy 2004; Roodenrys et al. 2002; API 2001. Group 7: Kanehira et al. 2011; Abdou et al. 2006. Group 8: Upton 2012; Winston and Maimes 2007; Mills and Bone 2005; API 2004; WHO 2004; Bone 2003; Hoffman 2003; Thomsen 2002; Williamson 2002; Blumenthal et al. 2000; Upton 1999; WHO 1999; Bradley 1992;
2References consulted for the doses: Group 1: CNF 2012; Bone 2003; Hoffman 2003; Bradley 1992; Williamson et al. 1988; BHP 1983; Ellingwood 1983; Felter and Lloyd 1983; Remington and Wood 1918; BPC 1911. Group 2: Williamson et al. 1988. Group 3: Jensen et al. 2010; Morgan and Stevens 2010; Quinn et al. 2010; Yurko-Mauro et al. 2010; Calabrese et al. 2008; Malaguanera et al. 2008; De Jesus Moreno Moreno 2003; Parnetti et al. 2001; Stough et al. 2001; Thal et al. 2000; Barbagallo et al. 1994; Pettegrewet al. 1994; Parnetti et al. 1993; Sano et al. 1992; Canal et al. 1991; Spagnoli et al. 1991. Group 4: Health Canada 2018; EMA 2013; Health Canada 2012; EMA 2010; ESCOP 2009; Bradley 2006; Taylor 2003. Group 6: Bone 2003; API 2001. Group 7: Kanehira et al. 2011; Powers et al. 2007; Yamakoshi et al. 2006. Group 8: Upton 2012; Winston and Maimes 2007; Mills and Bone 2005; API 2004; WHO 2004; Bone 2003; Hoffman 2003; Thomsen 2002; Williamson 2002; Blumenthal et al. 2000; Upton 1999; WHO 1999; Bradley 1992.
See Table 4 below.
All medicinal ingredients included in this monograph may be combined across all groups, with the following restrictions:
Use or Purpose Restrictions
Rules for Caffeine
Rules for sedatives
Additive Indication | Group 2 (e.g. Traditionally used in Herbal Medicine as a sleep aid) | ||
---|---|---|---|
Medicinal Ingredients | Maximum Daily Recommended Dose on PLA form | Maximum Daily Monograph Reference Dose | Percentage of the Maximum Daily Monograph Reference Dose (%) |
Eschscholzia californica (California poppy) |
0.5 g |
3 g |
0.5/3 = 16.67% |
Humulus lupulus (Hops) |
4 g |
6 g |
4/6 = 66.66% |
Hypericum perforatum (St John's wort) |
0.5 g |
12.6 g |
0.5/12.6 = 3.96% |
Sum of percentages |
87.3% |
The calculations are performed as follows:
Safety assessment - Sum of Percentages:
See Table 4 below.
Consult Table 4 for appropriate statements related to each medicinal ingredient. The medicinal ingredients in Table 4 are associated with the required numbered statements below.
Medicinal Ingredients | Risk Information | Durations of Use | Directions for use |
---|---|---|---|
1,3,7-trimethylxanthine (Caffeine) |
1 |
1 |
|
4-Aminobutanoic acid (GABA) |
4, 5, 13 |
3 |
|
Acetyl-L-Carnitine (Acetylcarnitine) |
5, 11, 21 |
||
Asparagus racemosus (Shatavari) |
6 |
||
Astragalus membranaceus (Astragalus) |
1 |
||
Avena sativa (Oat) |
4 |
||
Bacopa monnieri (Bacopa) |
5, 21 |
2 |
|
Cod liver oil |
1 |
||
Eleutherococcus senticosus (Eleuthero) |
1 |
1 |
|
Eschscholzia californica (California poppy) |
1 |
||
Fish oil |
1 |
||
Ganoderma lucidum (Reishi) |
1 |
1 |
|
Ginkgo biloba (Ginkgo) |
1 |
1 |
|
Glycyrrhiza glabra (Licorice) |
1 |
1 |
|
Humulus lupulus (Hops) |
1 |
||
Hypericum perforatum (St. John's wort) |
1 |
1 |
|
Ilex paraguariensis (Yerba mate) |
5, 12 |
||
L-5-Hydroxytryptophan (L-5-HTP) |
1 |
1 |
|
L-alpha-Glycerophosphorylcholine (Choline alfoscerate) |
5 |
||
L-Theanine |
1 |
||
L-Tyrosine |
1 |
1 |
1 |
Matricaria chamomilla (German chamomile) |
1 |
||
Melissa officinalis (Lemon balm) |
1 |
||
Nepeta cataria (Catnip) |
1 |
||
Ocimum tenuiflorum (Holy basil) |
1 |
||
Panax ginseng (Asian ginseng) |
1 |
1 |
|
Panax quinquefolius (American ginseng) |
1 |
||
Passiflora incarnata (Passionflower) |
1 |
||
Paullinia cupana (Guarana) |
5, 12 |
||
Phosphatidylserine |
1 |
||
Anemone pulsatilla (Pasqueflower) |
4, 8, 9, 10, 19 |
||
Rhodiola rosea (Rhodiola) |
1 |
||
Schisandra chinensis (Schisandra) |
7, 20 |
||
Scutellaria lateriflora (Skullcap) |
1 |
||
Stachys officinalis (Wood Betony) |
4, 5 |
||
Tilia cordata Small-leaf linden |
1 |
||
Tilia platyphyllos ((Large-leaf linden)) |
1 |
||
Tilia x europaea (European linden) |
1 |
||
Tinospora cordifolia (Guduchi) |
5 |
||
Turnera diffusa (Damiana) |
4, 7, 20 |
||
Valeriana officinalis (Valerian) |
1 |
||
Withania somnifera (Ashwagandha) |
1 |
||
Combination of ingredients resulting in a total caffeine content of 100 mg/day or more (e.g. Yerba mate and Guarana) |
as per the caffeine monograph |
||
Combination of two or more of the following ingredients: L-5-HTP, St John's Wort, and/or Passionflower |
18 |
References consulted: EMA 2013; Gardner and McGuffin 2013; Fiebich et al. 2011; AMR 2010; Morgan and Stevens 2010; Okun et al. 2010; ESCOP 2009; Calabrese et al. 2008; CPS 2008; Cornelis and El-Sohemy 2007; Powers et al. 2007; Bain et al.2006; Bradley 2006; Bui et al. 2006; Mills et al. 2006; Shils et al. 2006; Turner et al. 2006; Bouchard et al. 2005; Chandrasekaran et al. 2005; Haller et al. 2005; Noordzij et al. 2005; FDA 2004; Nathan et al. 2004; Bone 2003; Erner et al. 2003; Avisar et al. 2002; Barnes et al. 2002; Berardi et al. 2002; Thomsen 2002; Brinker 2001; Nathan et al. 2001; Stough et al. 2001; Arya et al. 2000; Vahedi et al. 2000; Jee et al. 1999; Mester et al. 1995; Bradley 1992; Zimmerman 1992; Creighton and Stanton 1990; Rai et al. 1990; FDA 1988; Jefferson 1988.
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Products containing Cod liver oil, Fish oil or Schizochytrium oil