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Source materials: ferritin, ferrocholinate, iron, carbonyl (not pentacarbonyl), iron, electrolytic, iron hydrolyzed animal protein (HAP) chelate, iron hydrolyzed vegetable protein (HVP) chelate, iron, reduced, iron (II) ascorbate/ferrous ascorbate, iron (II) aspartate/ferrous aspartate, iron (II) aspartate tetrahydrate/ferrous aspartate tetrahydrate, iron (II) bisglycinate/ferrous bisglycinate, iron (II) carbonate/ferrous carbonate, iron (II) chloride/ferrous chloride, iron (II) chloride tetrahydrate/ferrous chloride tetrahydrate, iron (II) citrate/ferrous citrate, iron (II) fumarate/ferrous fumarate, iron (II) gluceptate/ferrous gluceptate, iron (II) gluconate/ferrous gluconate, iron (II) gluconate dihydrate/ferrous gluconate dihydrate, iron (II) glutarate/ferrous glutarate, iron (II) glycine sulfate/ferrous glycine sulfate, iron (II) lactate/ferrous lactate, iron (II) lactate trihydrate/ferrous lactate trihydrate, iron (II) malate/ferrous malate, iron (II) oxalate/ferrous oxalate, iron (II) oxalate dihydrate/ferrous oxalate dihydrate, iron (II) succinate/ferrous succinate, iron (II) sulfate/ferrous sulfate, iron (II) sulfate dried (monohydrate)/ferrous sulfate dried (monohydrate), iron (II) sulfate heptahydrate/ferrous sulfate heptahydrate, iron (II) tartrate/ferrous tartrate, iron (III) ammonium citrate/ferric ammonium citrate, iron (III) citrate/ferric citrate, iron (III) glycerophosphate/ferric glycerophosphate, iron (III) phosphate/ferric phosphate, iron (III) pyrophosphate/ferric pyrophosphate, iron (III) sulfate/ferric sulfate, iron-dextrin complex, iron-sorbitol-citric acid complex
Note: The slash (/) indicates that the terms are synonyms.
Routes of administration: oral
Doses: Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewable tablets, caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons, or tablespoons are acceptable. This monograph is not intended to include food-like dosage forms such as bars, chewing gums, or beverages.
Table 1: Dose information for iron presented as dose per day
Life stage group Iron (mg/day) Minimum¹ Maximum² Infants 0 to 12 months 0.6 40 Children 1 to 3 years 4 to 8 years 0.6 0.6 40 40 Adolescents 9 to 13 years 14 to 18 years 0.6 1.4 40 45 Adults³ 19 years and up 1.4 45¹Based on approximately 5% of the highest RDA or AI (IOM 2006). ²Maximum dose based on the Tolerable Upper Intake Level (UL) which applies to total iron intake from food and supplements (IOM 2006). ³Includes pregnant and breast-feeding women.
Directions for use: Take with food. Take a few hours before or after taking other medications.
Duration of use: No statement required.
Uses and purposes: Statements to the effects of:
General: A factor in the maintenance of good health. Helps pregnant women meet the (Institute of Medicine’s) recommended intake for iron, when taken in conjunction with a healthy diet.
Specific: Helps to form red blood cells and helps in their proper function.
Dose-specific: For products providing daily doses of iron at or above the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) (adjusted for the life stage groups), either of the following use or purpose statements are acceptable provided that they are used verbatim: "Helps to prevent iron deficiency", or "Helps to prevent iron deficiency anaemia."
For products providing a daily dose of iron above 35 mg, per day, the specific use or purpose and/or the dose-specific use or purpose indicated above are required.
Your health care provider may have recommended this product for other conditions. Contact a health care provider if you have questions.
Cautions and warnings:
- When iron HAP or HVP chelate is used as a source material: For an adult subpopulation only.
- If the package contains more than the equivalent of 250 mg of elemental iron: Keep out of reach of children. There is enough drug in this package to seriously harm a child. (Note: This must be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour.)
Contraindications: No statement required.
Known adverse reactions: For products providing iron ranging from 16 to 35 mg, along with a daily prenatal multi-vitamin mineral supplement may result in constipation, diarrhoea, and/or vomiting in pregnant women due to the high intake of iron. For products providing iron at doses greater than 36 mg, per day, the following statement is required: Some people may experience constipation, diarrhoea, and/or vomiting.
Before taking any new medications, including natural health products, speak to your physician, pharmacist, or other health care provider. Tell your health care provider about any natural health products you may be taking.
Nonmedicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
Specifications: Must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs. The medicinal ingredient may comply with the specifications outlined in the applicable iron monographs published in the USA (USP), British (BP) and European (Ph.Eur.) Pharmacopoeias.
Health Canada. Drugs & Health Products. Monograph - Iron - Draft. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_iron-fer_e.html
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