VITAMIN D (>1,000 - 2,500 IU)

Monograph: Vitamin D (1,000-2,500 IU) (English) (PDF Version - 60 ko)

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 ingredients.

Notes

  • Text in parentheses is additional optional information which can be included on the label at the applicant's discretion.
  • The solidus (/) indicates that either term and/or statement may be selected on the label.
  • Other Multi-vitamin/mineral supplement monograph claims are not permitted, as the risk-benefit profile for products providing more than 1,000 IU of vitamin D per day was deemed acceptable only for a specific subpopulation associated with the claims listed in this monograph, and not for general supplementation.
  • In addition, although NNHPD included a few complementary ingredients in this monograph, high dose vitamin D can only be combined with the specific ingredients listed in this monograph.

This monograph cannot be combined with any other monograph.

Date

June 26, 2026

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information for the medicinal ingredient vitamin D
Proper Name(s) Common Name(s) Source information
Source ingredient(s)
Vitamin D
  • Vitamin D
  • Vitamin D2
 Ergocalciferol
  • Vitamin D
  • Vitamin D3
 Cholecalciferol

References: Proper name: FCC 2025; RSC 2025; Brayfield and Cadart 2024; Common names: FCC 2025; RSC 2025; Brayfield and Cadart 2024; Source information: FCC 2025; RSC 2025; Brayfield and Cadart 2024.

Table 2. Proper name(s), Common name(s), Source information for complementary ingredients
Proper name(s) Common name(s) Source information1,2
Source ingredient(s)
Calcium Calcium
  • Calcium acetate
  • Calcium amino acid chelate
  • Calcium ascorbate
  • Calcium aspartate
  • Calcium bisglycinate
  • Calcium carbonate
  • Calcium chloride
  • Calcium chloride, dihydrate
  • Calcium chloride, hexahydrate
  • Calcium citrate
  • Calcium citrate malate
  • Calcium citrate, tetrahydrate
  • Calcium diglutamate
  • Calcium D-pantothenate
  • Calcium fumarate
  • Calcium glubionate
  • Calcium glubionate, monohydrate
  • Calcium gluceptate
  • Calcium gluconate
  • Calcium gluconate, monohydrate
  • Calcium glutamate
  • Calcium glutarate
  • Calcium glycerophosphate
  • Calcium hydrolyzed animal protein (HAP) chelate
  • Calcium hydrolyzed vegetable protein (HVP) chelate
  • Calcium hydroxide
  • Calcium hypophosphite
  • Calcium lactate
  • Calcium lactate gluconate
  • Calcium lactate, monohydrate
  • Calcium lactate, pentahydrate
  • Calcium lactate, trihydrate
  • Calcium lactobionate, dihydrate
  • Calcium levulinate
  • Calcium levulinate, dihydrate
  • Calcium lysinate
  • Calcium magnesium citrate
  • Calcium malate
  • Calcium orotate
  • Calcium oxide
  • Calcium phosphate, dibasic
  • Calcium phosphate, dibasic, dihydrate
  • Calcium phosphate, monobasic
  • Calcium phosphate, tribasic
  • Calcium pidolate
  • Calcium pyrophosphate
  • Calcium pyruvate
  • Calcium silicate
  • Calcium sodium lactate
  • Calcium succinate
  • Calcium sulfate
  • Calcium sulfate, dihydrate
  • Calcium sulfate, hemihydrate
  • Calcium L-threonate
  • Dicalcium malate
  • Dolomite
  • Durapatite
Magnesium Magnesium
  • Calcium magnesium citrate
  • Dolomite
  • Magnesium acetate
  • Magnesium acetate, tetrahydrate
  • Magnesium N-acetyltaurinate
  • Magnesium amino acid chelate
  • Magnesium ascorbate
  • Magnesium ascorbate, monohydrate
  • Magnesium aspartate
  • Magnesium aspartate, dihydrate
  • Magnesium aspartate hydrochloride, trihydrate
  • Magnesium aspartate, tetrahydrate
  • Magnesium bisglycinate
  • Magnesium carbonate
  • Magnesium chloride
  • Magnesium chloride, hexahydrate
  • Magnesium citrate
  • Magnesium citrate, tribasic
  • Magnesium citrate malate
  • Magnesium dibutyrate
  • Magnesium fumarate
  • Magnesium gluceptate
  • Magnesium gluconate
  • Magnesium gluconate, dihydrate
  • Magnesium glutarate
  • Magnesium glycerophosphate
  • Magnesium hydrolyzed animal protein (HAP) chelate
  • Magnesium hydrolyzed vegetable protein (HVP) chelate
  • Magnesium hydroxide
  • Magnesium hydroxide carbonate
  • Magnesium lactate
  • Magnesium L-threonate
  • Magnesium lysinate
  • Magnesium lysyl glycinate
  • Magnesium malate
  • Magnesium orotate
  • Magnesium orotate, dihydrate
  • Magnesium oxide
  • Magnesium phosphate, dibasic
  • Magnesium phosphate, dibasic, mixed hydrates
  • Magnesium phosphate, dibasic, trihydrate
  • Magnesium phosphate, monobasic
  • Magnesium phosphate, tribasic
  • Magnesium phosphate, tribasic, octahydrate
  • Magnesium phosphate, tribasic, pentahydrate
  • Magnesium phosphate, tribasic, tetrahydrate
  • Magnesium pidolate
  • Magnesium succinate
  • Magnesium sulfate
  • Magnesium sulfate, heptahydrate
  • Magnesium sulfate, monohydrate
  • Magnesium sulfate, trihydrate
  • Magnesium taurate
  • Magnesium trisilicate
Vitamin K2 Vitamin K2
  • Menaquinone 4
  • Menaquinone 6
  • Menaquinone 7
  • Menaquinones
  • Menatetrenone
Zinc Zinc
  • Zinc acetate
  • Zinc acetate, dihydrate
  • Zinc amino acid chelate
  • Zinc arginate
  • Zinc ascorbate
  • Zinc aspartate
  • Zinc bisglycinate
  • Zinc carbonate
  • Zinc chloride
  • Zinc citrate
  • Zinc citrate, dihydrate
  • Zinc citrate, trihydrate
  • Zinc fumarate
  • Zinc gluconate
  • Zinc gluconate glycine
  • Zinc glutarate
  • Zinc glycerate
  • Zinc histidinate
  • Zinc hydrolyzed animal protein (HAP) chelate
  • Zinc hydrolyzed vegetable protein (HVP) chelate
  • Zinc lactate
  • Zinc lysinate
  • Zinc malate
  • Zinc methionine
  • Zinc monomethionine
  • Zinc orotate
  • Zinc oxide
  • Zinc phosphate
  • Zinc picolinate
  • Zinc pidolate
  • Zinc propionate
  • Zinc succinate
  • Zinc sulfate
  • Zinc sulfate, heptahydrate
  • Zinc sulfate, monohydrate

Reference: NNHPD 2026.

1For complementary ingredients both the synthetic and non-synthetic forms are supported by this monograph. However, if non-synthetic, the ingredient must be isolated and purified from a source material listed in its Natural Health Products Ingredients Database (NHPID) entry. For example, calcium sourced from bone meal, coral calcareous skeleton, or oyster shell is also acceptable. All medicinal ingredients isolated from source materials must be of an acceptable purity. This monograph does not support extracts.
2When applicable, any hydrated form of a source ingredient listed above would be acceptable on the marketed label as long as it is included in the NHPID.

Route of administration

Oral

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

  • Helps to prevent vitamin D deficiency (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).
  • Vitamin D intake, when combined with sufficient calcium, a healthy diet and regular exercise may reduce the risk of developing osteoporosis in people with vitamin D deficiency (Kahwati et al. 2018; Shils et al. 2006; NIH 2001; Groff and Gropper 2000).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Note: Adults 19 years and older is the only acceptable subpopulation for the source ingredients HAP or HVP and for zinc sourced from picolinate.

Quantity(ies)

Table 3. Daily doses for the medicinal ingredient Vitamin D
Subpopulation(s) Medicinal ingredient Minimum1 Maximum2
Adults 18 years and older Vitamin D 25 µg (> 1,000 IU*) ≤ 62.5 µg (≤ 2,500 IU*)

1This value is based on the previous Prescription Drug List limit (HC 2020).
2This value is based on the Prescription Drug List limit amended in 2021 (HC 2021).

Notes

  • The quantity of vitamin D per dosage unit must always be provided in micrograms (µg).
  • Optional: *International Units (IU) may be provided as additional quantity per dosage unit.
  • Conversion factor: 1 IU of vitamin D = 0.025 µg cholecalciferol or ergocalciferol (IOM 2006).

Table 4. Daily doses for complementary ingredients1
Subpopulation(s) Complementary ingredient Minimum Maximum
Adults 18 years Calcium 65 mg 1,500 mg
19 years and older
18 years Magnesium 20 mg 350 mg
19 years and older 500 mg
18 years Vitamin K2 6 mcg 75 mcg
19 years and older 120 mcg
18 years Zinc (from non-picolinate sources) 0.7 mg 34 mg
19 years and older 50 mg
18 years Zinc (from picolinate sources) - -
19 years and older 0.7 mg 25 mg

Reference: NNHPD 2026.

1Any restrictions from the Multi-vitamin/mineral supplements monograph also apply.

Direction(s) for use

Products that do not contain calcium at therapeutic dose

Take with an adequate intake of calcium.

Products containing calcium or zinc

  • Take with food (NNHPD 2026).
  • Take a few hours before or after taking other medications or health products (NNHPD 2026).

Duration(s) of use

Products containing zinc sourced from picolinate

Ask a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 12 weeks (NNHPD 2026).

Other products

Ask a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 6 months (BfR 2020).

Risk information

Caution(s) and warning(s)

All products except products containing zinc sourced from picolinate requiring a contraindication

  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding.

All products

  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have kidney disorders (NIH 2024; BfR 2020).
  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking other supplements or products containing vitamin D or vitamin D analogues.
  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking any medications including antacids, anticonvulsants, digoxin, cholestyramine, colestipol, mineral oil, steroids, statins or thiazide diuretics (NNHPD 2021; BfR 2020).
  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use to determine if you would benefit from additional vitamin D as 15-20 mcg (600-800 IU) of vitamin D per day is an adequate quantity for most individuals.

Products containing vitamin K2

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking blood thinners (NNHPD 2026).

Products providing 25-34 mg of zinc per day for adults 18 years or 31-50 mg of zinc per day for adults 19 years and older

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are unsure whether you are taking enough copper as zinc supplementation can cause a copper deficiency (NNHPD 2026).

Contraindication(s)

All products

Do not use if you have hypercalcemia and/or hypercalciuria (NIH 2024; BfR 2020).

Products containing zinc sourced from picolinate

Do not use if you are pregnant or breastfeeding (NNHPD 2026).

Known adverse reaction(s)

All products

Stop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if the following early symptoms of hypercalcemia occur: weakness, fatigue, drowsiness, headache, lack of appetite, dry mouth, metallic taste, nausea, vomiting, vertigo, ringing in the ears, lack of coordination and muscle weakness or if you develop any other symptom (NIH 2024; BfR 2020).

Products providing more than 350 mg of magnesium per day

When using this product you may experience diarrhea (NNHPD 2026).

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References cited

  • BfR 2020: Vitamin D: consumption of high-dose food supplements is unnecessary; BfR Opinion No 035; 2020. [Accessed 2026March 18]. Available from: https://www.bfr.bund.de/cm/349/vitamin-d-consumption-of-high-dose-food-supplements-is-unnecessary.pdf
  • Brayfield A, Cadart C, editors. Martindale: The Complete Drug Reference. London (GB): Pharmaceutical Press; 2024. [Accessed 2026 March 18]. Available from: https://www.medicinescomplete.com/#/browse/martindale
  • FCC 2025: Food Chemicals Codex, 14th edition. Rockville (MD): The United States Pharmacopeial Convention; 2025.
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • HC 2021: Health Canada's Prescription Drug List; Vitamin D, effective date: 2021-02-24. [Accessed 2026 March 18]. Available from: https://hpr-rps.hres.ca/pdl-phu.php
  • HC 2020: Health Canada: Notice of Intend to Amend the Prescription Drug List: Vitamin D; 2020. [Accessed 2026 March 18]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/notice-intent-vitamin-d.html
  • IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
  • IOM 1997: Institute of Medicine. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academy Press; 1997.
  • Kahwati LC, Weber RP, Pan H, Gourlay M, LeBlanc E, Coker-Schimmer M, Viswanathan M. Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Community-Dwelling Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA 2018;319(15):1600-1612.
  • NIH 2024: National Institute of Health: Vitamin D Fact Sheet for Health Professionals; 2024. [Accessed 2026 March 18]. Available from: https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/
  • NIH 2001: National Institute of Health. Osteoporosis Prevention, Diagnosis, and Therapy. NIH Consensus Development Panel on Osteoporosis Prevention, diagnosis and therapy. JAMA 2001;17(1):1-36.
  • NNHPD 2026: Natural and Non-Prescription Health Products Directorate. Multi-Vitamin/Mineral Supplements monograph. [Accessed 2026 May 29]. Available from: https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=multi_vitmin_suppl3&lang=eng
  • NNHPD 2021. Natural and Non-Prescription Health Products Directorate. Internal evidence and HC's product monographs.
  • RSC 2025: Royal Society of Chemistry: The Merck Index Online; 2025. [Accessed 2026 March 18]. Available from: https://merckindex.rsc.org/
  • Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease. 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.

Version History

Publication date Update type Summary of main updates (from March 2026)
2026-06-26 Minor updates
  • Inclusion of 4 complementary ingredients deemed acceptable in combination with high-dose vitamin D according to the recommended conditions for use. Directions for use, duration of use and risk statements for these complementary ingredients were also added
  • Revision of the reference to the Food Chemicals Codex and addition of the reference to the multivitamin/mineral supplements monograph for information regarding complementary ingredients
2026-03-27 Minor updates
  • Introductory notes
  • Duration of use wording
  • Risk statement wording
  • Inclusion of a Product Facts Table example
  • Reference section
  • Inclusion of version history information
2021-07-23 Initial version –

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