維生素及礦物質製劑基準草案(英文)-980203

Monograph for Vitamin and Mineral Pharmaceutical Products Review and Approval

I. Scope

1. The Vitamin and Mineral products established by this Monograph represent the single or complex, orally-taken pharmaceutical products.

2. If the daily dosage limitation of an ingredient contained in a product is exceeded the daily dosage limitation for OTC Drug, the product is classified as Prescription Drug.

3. If a product, which contains the vitamins not listed in this Monograph, or the vitamin ingredient sources or salts not listed in this Monograph, its classification is to be reviewed case by case.

4. If a product, which indication scope is beyond the indications listed for OTC Drug and Quasi Drug (Category B) in this Monograph, its classification is to be reviewed case by case.

5. The orally-taken products established by this Monograph represent dosage forms, such as Capsules, Tablets, Syrup, Solution, etc. And, such dosage form must be the approved form to be used in Vitamin and Mineral products.

II. Compounding Ingredients

1. The category and potency of compounding ingredients：

(1) The compounding Vitamin and Mineral ingredients established by this Monograph (also called as compound ingredients) are presented in Table I.

1 維生素及礦物質製劑基準草案(英文)-980203

(2) The Table I establishes the upper daily dosage limitation of compounding ingredients of OTC Drug or Quasi Drug (Category B).

(3) If the daily dosage limitation of any ingredient in a product is exceeded the upper daily dosage limitation of Quasi Drug in Table I, the product is classified as OTC Drug. If the daily dosage limitation of any ingredient in a product is exceed the upper daily dosage limitation of OTC Drug in Table I, the product is classified as Prescription Drug.

(4) If any ingredient of a product is not listed in this Monograph Table I, please submit the relevant documents to explain the relationship of that ingredient to the compound ingredient source listed in Table I, in order to verify it is not a new chemical entity.

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Vitamin A*2 Cod liver oil Active Ingredient source Retinol Retinol acetate 10,000 IU 10,000IU ◎ as Vitamin A Fat Soluble Vitamin Retinol palmitate Strong cod liver oil Vitamin A fatty acid Ester in oil Vitamin A oil β-Carotene *3 Active Ingredient source

10,000 IU 10,000IU ○ as Vitamin A β-Carotene

2 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Vitamin D ＊4

Active Ingredient source Cholecalciferol (Vit. D3) 1000 IU 800 IU ◎ as Vitamin D Ergocalciferol (Vit. D2)

Ergocalciferol acetate Vitamin E ＊5 d-α-Tocopherol d-α-Tocopherol acetate Active Ingredient source d-α-Tocopherol succinate (d-α-Tocopheryl acid succinate) dl-α-Tocopherol 400 IU 400 IU ◎ as Vitamin E Fat Soluble Vitamin dl-α-Tocopherol acetate dl-α-Tocopherol succinate

(dl-α-Tocopheryl acid succinate) dl-α-Tocopherol calcium succinate （account by dl-α- Tocopherol succinate）

Vitamin K

Active Ingredient source Phytomenadione (Vit K1, Phylloquinone、Phytonadione)

Menaquinone (Vit K2) 1mg 500 μg ○

Menadione (Vit K3) Menadione sodium bisulfite

(Vit K3)

Vitamin B1 Benfotiamine （Benzoylthiamine as Thiamine Water Soluble Vitamin Water monophosphate） hydrochloride Active Ingredient source Bisbentiamine（Benzoylthiamine as Thiamine disulfide） hydrochloride Bisibuthiamine 250 mg 50 mg ◎ Bisthiamine nitrate（Thiamine as Thiamine disulfide nitrate） disulfide

Cocarboxylase

（Thiamine pyrophosphate） Cycothiamine

3 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Dibenzoyl thiamine Dibenzoyl thiamine hydrochloride as Thiamine Dicethiamine hydrochloride hydrochloride Fursultiamine

Active Ingredient source as Fursultiamine hydrochloride Fursultiamine Octotiamine Prosultiamine 250 mg 50 mg ◎ Prothiamine

as Thiamine HCl or Thiamine dicetylsulfate Thiamine nitrate

Water Soluble Vitamin Water Thiamine disulfide Thiamine hydrochloride Thiamine nitrate

Vitamin B2

Active Ingredient source Riboflavin Riboflavin phosphate as Riboflavin

100 mg 100 mg ◎ Riboflavin phosphate sodium as Riboflavin Riboflavin tetrabutyrate

(Riboflavin butyrate)

Pantothenic acid

Calcium d-pantothenate

Active Ingredient source Calcium dl-pantothenate

d-Panthenol 1000 mg 500 mg ◎

dl-Panthenol

Sodium d-pantothenate

Sodium dl-pantothenate

4 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation

Vitamin B6

Pyridoxal Pyridoxal hydrochloride

Active Ingredient source Pyridoxal-5-phosphate （calcium salt） Pyridoxal phosphate 200 mg 80 mg ◎ Pyridoxal phosphate Sodium Pyridoxine Pyridoxine hydrochloride

Pyridoxine-5-phosphate Pyridoxamine pyridoxamine-5-phosphate Vitamin B 12

Water Soluble Vitamin Water ( Cobalamins) Cyanocobalamin Active Ingredient source Hydroxocobalamin 1,000 μg 1,000 μg ◎ as Hydroxocobalamin acetate Hydroxocobal -amin Hydroxocobalamin hydrochloride

Mecobalamin/ Methylcobalamin Vitamin C

Ascorbic Acid Calcium ascorbate Active Ingredient source Sodium ascorbate as Ascorbic 2,000 mg 1,000 mg ◎ L-Ascorbyl Palmitate Acid L-Ascorbyl Steartate

Magnesium ascorbate Niacinamide ascorbate Potassium ascorbate

5 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Nicotinamide Active Ingredient source Water Soluble Vitamin Water Niacinamide Ascorbate 500 mg 100mg ◎

Nicotinamide (Niacinamide)

Nicotinic Acid、 Niacin 450 mg 100mg ◎

Folic Acid 1,000 μg 800 μg ○ Biotin 2500μg 500μg ○ Calcium Calcium Oxide Calcium Carbonate Calcium Phosphate

Monobasic Calcium Phosphate

Dibasic Anhydrou Calcium Phosphate

Tribasic Calcium Phosphate

Active Ingredient source Dibasic Mineral Calcium Lactate Calcium Gluconolactate 1800mg 1800mg ◎ as Calcium Calcium L-Threonate Calcium Citrate Calcium glycerophosphate Calcium gluconate Precipitated calcium Carbonate Ostreae Testa Pulverata Haliotidis Concha Bone meal（Calcium & Phosphorus

should be labeled） Calcium acetate Calcium ascorbate Calcium bisglycinate

Calcium chloride

6 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Calcium chloride dehydrate Calcium chloride hexahydrate Calcium citrate malate Calcium citrate tetrahydrate Calcium fumarate Calcium glubionate Calcium glubionate monohydrate Calcium gluceptate Calcium gluconate monohydrate Calcium glutarate Calcium hydroxide

Active Ingredient source Calcium lactate gluconate

Mineral Calcium lactate pentahydrate Calcium lactate trihydrate Calcium lactobionate dihydrate

Calcium levulinate 1800mg 1800mg ◎ as Calcium

Calcium levulinate dihydrate Calcium malate Calcium pidolate Calcium pyrophosphate Calcium silicate Calcium sodium lactate Calcium succinate Calcium sulfate Calcium sulfate dihydrate Coral Dolomite Oyster shell Calcium Pearl

Calcium Fluoride Casein Calcium Calcium amino acid chelate Calcium Phosphate

Dibasic Hydrous

7 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation

Active Ingredient source Calcium Hydrogen Phosphate

Dihydrate Calcium Hydrogen Phosphate Tricalcium Phosphate 1800mg 1800mg ◎ as Calcium Dicalcium Phosphate Calcium Phosphate anhydrous Chromium Chromium（III） bisglycinate

（Chromic bisglycinate） Chromium（III）chloride

Mineral （chromic chloride） Chromium（III）chloride

hexahydrate（chromic chloride hexahydrate） Chromium（III）citrate（chromic

citrate） Active Ingredient source Chromium（III）diniconitinate as 500μg 200μg ○ （chromic dinicontinate） Chromium Chromium（III）-enriched yeast

（chromic-enriched yeast）

Chromium（III）fumarate

（chromic fumarate） Chromium（III） glutarate

（chromic glutarate） Chromium（III） HAP chelate

（chromic HAP chelate） Chromium（III） HVP chelate

（chromic malate） Chromium（III） nicotinate

（chromic nicotinate） Chromium（III） pidolate

（chromic pidolate） Chromium（III） polynicotinate

（chromic polynicotinate） Chromium（III） potassium sulfate dodecahydrate（chromic potassium sulfate dodecahydrate） 8 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Active Ingredient source Chromium（III） succinate

（chromic succinate） Chromium（III） sulfate（chromic 500μg 200μg ○ as sulfate） Chromic acetate monohydrate Chromium

Chromic picolinate Niacin bound chromium Chromic nitrate Copper Copper oxide Calcium copper edentate Copper（II） acetate

（Cupric acetate） Copper（II）bisglycinate

Mineral （Cupric bisglycinate） Copper（II）carbonate

Active Ingredient source （Cupric carbonate） Copper（II）chloride（Cupric

chloride） Copper（II）chloride dehydrate 9mg 8mg ○ as Copper （Cupric chloride dihydrate） Copper（II）citrate

（Cupric citrate） Copper（II）fumarate

（Cupric fumarate） Copper（II）gluconate

（Cupric gluconate） Copper（II）glutarate

（Cupric glutarate） Copper（II）HAP (hydrolyzed animal protein) chelate（Cupric HAP chelate） Copper（II）HVP (hydrolyzed vegetable protein) chelate（Cupric HVP chelate） Copper（II）malate（cupric malate）

9 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation

Active Ingredient source Copper（II）succinate

（Cupric succinate） Copper（II）sulfate 9mg 8mg ○ as Copper （Cupric sulfate） Copper（II）sulfate petahydrate

（Cupric sulfate petahydrate） Iodine Active Ingredient source Potassium Iodide

Potassium Iodate 500μg 195ug ○ as Iodide

Sodium Iodide

Mineral Iron Iron, reduced Ferric Pyrophosphate (iron

Pyrophosphate) Iron, Carbonyl

Iron, Electrolytic Ferric Ammonium

Active Ingredient source Citrate Ferric Chloride 60 mg 22.5 mg ◎ as Iron Ferric Citrate Ferrous Sulfate Ferrous Lactate

Iron and Sodium

Succinate Citrate Ferric Phosphate Ferrous G1cconate Ferrous Fumarate Iron Lactate Ferrous Bisglycinate Chelate Ferritin Ferrocholinate

10 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Ferrous ascorbate

（Iron(II) ascorbate） Ferrous aspartate

（Iron(II) aspartate） Ferrous aspartate tetrahydrate

（Iron aspartate tetrahydrate） Ferrous bisglycinate

（Iron(II) bisglycinate） Ferrous carbonate

（Iron(II) carbonate） Ferrous chloride

（Iron(II) chloride） Ferrous chloride tetrahydrate

（Iron(II) chloride trtrahydrate）

Active Ingredient source Ferrous citrate（Iron(II) citrate） Mineral Ferrous gluceptate

（Iron(II) gluceptate）

Ferrous gluconate dehydrate 60 mg 22.5 mg ◎ as Iron （Iron(II) gluconate dihydrate） Ferrous glutarate

（Iron(II) glutarate） Ferrous glycine sulfate

（Iron(II) glycine sulfate） Ferrous lactate trihydrate

（Iron(II) lactate trihydrate） Ferrous malate （Iron(II) malate） Ferrous oxalate（Iron(II) oxalate） Ferrous oxalate dehydrate

（Iron(II) oxalate dihydrate） Ferrous succinate

（Iron(II) succinate） Ferrous sulfate dried (monohydrate) （Iron sulfate dried(monohydrate)） Ferrous sulfate heptahydrate

（Iron(II) sulfate heptahydrate）

11 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Ferrous tartrate Active Ingredient source

（Iron(II) tartrate） Ferric glycerophosphate 60 mg 22.5 mg ◎ as Iron （Iron(II) glycerophosphate） Ferrous fumarate Ferrous Sulfate Dehydrate

Magnesium Magnesium acetate Magnesium acetate tetrahydrate Magnesium ascorbate Magnesium aspartate Magnesium bisglycinate Magnesium carbonate Magnesium chloride Magnesium chloride hexahydrate Magnesium citrate

Active Ingredient source Magnesium fumarate Mineral Magnesium gluceptate 600 mg 600 mg ○ as Magnesium gluconate Magnesium (Magnesium gluconate dehydrate) Magnesium glutarate

Magnesium glycerophosphate Magnesium hydroxide Magnesium lactate Magnesium malate Magnesium oxide

Magnesium phosphate dibasic trihydrate（Magnesium hydrogen phosphate trihydrate 、 Dimagnesium phosphate trihydrate） Magnesium phosphate dibasic

12 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Magnesium phosphate tribasic tetra-, penta-, or octahydrate

Active Ingredient source （Trimagnesium phosphate tetra-, penta-, or octahydrate） Magnesium phosphate tribasic 600 mg 600 mg ○ as Magnesium pidolate Magnesium Magnesium succinate

Magnesium sulfate Magnesium sulfate heptahydrate Manganese Manganese（II） bisglycinate

（Manganous bisglycinate） Manganese（II） chloride

（Manganous chloride） Manganese（II） chloride tetrahydrate（Manganous chloride tetrahydrat e） Manganase（II） citrate

（Manganous citrate） Mineral Manganese（II） gluconate

Active Ingredient source /Manganous gluconat

Manganese（II）glycerophosphate as 10 mg 9 mg ○ （Manganous glycerophosphate） Manganese Manganese（II）HAP chelate

（Manganous HAP chelate）

Manganese（II）HVP chelate

（Manganous HVP chelate） Manganese（II）sulfate

（Manganous sulfate） Manganese（II）sulfate monohydrate（Manganous sulfate monohydrate） Manganese（II）sulfate tetrahydrate（Manganous sulfate tetrahydrate） Manganese（IV）oxide

13 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Phosphorus Bone meal（Calcium & Phosphorus

should be labeled） Calcium glycerophosphate Calcium phosphate dibasic Calcium phosphate monobasic Calcium phosphate tribasic Potassium phosphate dibasic

Active Ingredient source Potassium phosphate monobasic 1800mg 1200 mg ○ as Sodium phosphate dibasic Phosphorus Sodium phosphate dibasic

dodecahydrate Sodium phosphate dibasic

hetahydrate Sodium phosphate monobasic Sodium phosphate monobasic

dihydrate Mineral Sodium phosphate monobasic

monohydrate

Calcium phosphate dibasic

（Anhydrous） Selenium Monohydrated selenium dioxide Selenium citrate Active Ingredient source Selenium HAP chelate Selenium HVP chlelate Selenium yeast 400μg 200μg ○ as Selenim Seleniumcysteine

Seleniummethionine Sodium selenate Sodium selenite Zinc

Zinc acetate 50 mg 30 mg ○ as Zinc Zinc acetate dihydrate 14 維生素及礦物質製劑基準草案(英文)-980203

Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Zinc bisglycinate Zinc chloride Zinc citrate Zinc fumarate Zinc gluconate Zinc glutarate Zinc glycerate Active Ingredient source Zinc HAP chelate 50 mg 30 mg ○ as Zinc Mineral Zinc HVP chelate Zinc malate Zinc monomethionine

Zinc oxide Zinc phosphate Zinc succinate Zinc sulfate Zinc sulfate heptahydrate Zinc Stearate

＊1. If conversion is indicated in the Remark column of an ingredient, its dosage must be calculated based on the ingredient dosage after the conversion.

＊2. Activity of Vitamin A

Ingredient (1 mcg) =μg RAE = IU of Vitamine A of Vitamine A 1μg All-trans beta-carotene 0.50 1.67 All-trans rentinol 1.00 3.33 All-trans rentinol acetate 0.87 2.90 All-trans rentinol palmitate 0.55 1.82

15 維生素及礦物質製劑基準草案(英文)-980203

＊3. Activity of β-Carotene calculated as Vitamin A 1 IU Vit A ＝ 2 IU β - carotene ＝ 0.6μg β - carotene

＊4. Activity of Vitamin D 1 IU of Vitamin D ＝0.025μg Cholecalciferol ＝0.025μg Ergocalciferol

＊5. Activity of Vitamin E

Ingredient (1 mg) ＝mg d-α-Tocopheryl = IU of Vitamin E Equivalent of Vit E 1 mg dl-α-Tocopheryl Acid Succinate 0.59 0.89 dl-α-Tocopheryl Acetate 0.67 1 dl-α-Tocopherol 0.71 1.1 d-α-Tocopheryl Acid Succinate 0.83 1.21 d-α-Tocopheryl Acetate 0.91 1.36 d-α-Tocopherol (Natural-Tocopherol) 1 1.49

2. Formulation Rules

（1）◎ : Can stand as single-ingredient formula;

○: Must stand as a complex formula.

（2） A formulation must contain a least one

"single-ingredient-standable" ingredient.

（3） Minerals, except Calcium and Iron, must stand as complex formula and follow the formulation rule of #2 above.

16 維生素及礦物質製劑基準草案(英文)-980203

III、Dosage and Administration

Dosage information for vitamins based on age：

1. OTC Drug

Above 15 years of age：take adult dosage Above 11 but under 15 years of age：take 2/3 of adult dosage Above 7 but under 11 years of age：take 1/2 of adult dosage Above 3 but under 7 years of age：take 1/3 of adult dosage Above 1 but under 3 years of age：take 1/4 of adult dosage Under 1 year of age：consult doctor or pharmacist before use

2. Quasi Drug (Category B)

Above 15 years of age：take adult dosage Above 11 but under 15 years of age：take 2/3 of adult dosage Above 7 but under 11 years of age：take 1/2 of adult dosage Above 3 but under 7 years of age：take 1/3 of adult dosage Under 3 years of age：not recommend to use by self medication

IV. Indications

1. Labeling Indications for OTC Drug

Ingredient Indication Vitamin A Relieve the symptoms of eye dryness, nyctalopia, etc.

B-Carotene Relieve the symptoms of eye dryness, nyctalopia, etc. Vitamin D Relieve the symptoms of Osteomalacia, rickets, etc. Relieve the symptom of Hypocalcaemia associated with chronic renal malfunction. Relieve the symptom of Hypoparathyroidism.

17 維生素及礦物質製劑基準草案(英文)-980203

Ingredient Indication Vitamin E Relieve the symptoms caused by peripheral blood not flowing smoothly, e.g. neck & shoulder ache, arm & leg numbness, chills, frostbite, etc.

Vitamin B1 Relieve the symptoms of neuritis, neural pain, muscle pain, arthralgia, etc. Relieve Beriberi.

Vitamin B2 Relieve the symptoms of Stomatitis, Cheilitis, Glossitis, and angular Stomatitis, etc. Relieve the symptoms of eczema, dermatitis, Acne Vulgaris, etc. Pantothenic Acid Pantothenic Acid deficiency

Vitamin B6 Relieve the symptoms of Stomatitis, Cheilitis, Glossitis, and Angular Stomatitis, etc. Relieve the symptoms of eczema, dermatitis, skin macula, Urticaria, etc. Relieve the symptoms of pregnancy morning sickness, nausea, pregnancy uncomfortableness, etc.

Vitamin B12 Relieve Pernicious Anemia, Macrocytic Anemia, and Dystropic Anemia. Relieve anemia induced by chronic disease or as healthy supplement therapy. Vitamin C Relieve the symptoms of scurvy, gums bleeding, Stomatitis, Glossitis, etc. Relieve the symptoms of Dermatitis, Melasma, Freckle, Hyperpigmentation Abnormality, etc. Nicotinamide ＆ Relieve Dermatitis and Nicotinic Acid Deficiency. Nicotinic Acid Calcium Relieve the symptoms of Osteomalacia, rickets, etc. Relieve the symptom of Hypocalcaemia associated with chronic renal malfunction. Relieve the symptom of Hypoparathyroidism. Iron Relieve Iron Deficiency Anemia

18 維生素及礦物質製劑基準草案(英文)-980203

2. Labeling Indications for Quasi Drug (Category B)

Ingredient Indication

Prevent Vitamin A Deficiency (e.g. eye dryness, nyctalopia, Vitamin A etc.) β-Carotene As Vitamin A source to prevent Vitamin A Deficiency (e.g. eye dryness, nyctalopia, etc.) Vitamin D Prevent Vitamin D Deficiency (e.g. Osteomalacia, rickets, etc.) Vitamin E Prevent Vitamin E Deficiency (e.g. neck & shoulder ache, arm & leg numbness, chills, frostbite, etc.)

Vitamin B1 Prevent Vitamin B1 Deficiency (e.g. neuritis, neural pain, muscle pain, Arthralgia, beriberi, etc.)

Vitamin B2 Prevent Vitamin B2 Deficiency (symptoms e.g. Stomatitis, Cheilitis, Glossitis, Angular stomatitis, and Eczema, Dermatitis, and Acne Vulgaris, etc.) Pantothenic acid Prevent Pantothenic Acid Deficiency.

Vitamin B6 Prevent Vitamin B6 Deficiency (symptoms e.g. Stomatitis, Cheilitis, Glossitis, Angular stomatitis, and Eczema, Dermatitis, Skin Macula, Urticaria, and pregnancy morning sickness, nausea, and pregnancy uncomfortableness, etc.

Vitamin B12 Prevent Vitamin B12 Deficiency (e.g. Pernicious Anemia, Macrocytic Anemia, and Dystropic Anemia.) Vitamin C Prevent Vitamin C Deficiency (e.g. scurvy, gums bleeding, Hyperpigmentation Abnormality, etc.) Nicotinamide ＆ Prevent Nicotinic Acid Deficiency (symptoms e.g. Nicotinic Acid Dermatitis, etc.) Calcium Prevent Calcium Deficiency (e.g. Osteomalacia, rickets, etc.)

Iron Prevent Iron Deficiency (e.g. Iron Deficiency Anemia)

19 維生素及礦物質製劑基準草案(英文)-980203

3. Indications for Complex Formulations (The applicant can either apply the labelling indications of each ingredient contained in the formulation or apply the indications below)

（3）Indications for OTC Complex Formulations

Nutrient supplement, ill recovery. Vitamin B Complex Enhance the growth of babies and children Auxiliary therapy for thermal contagious patients. Relieve fatigue and tiredness. Auxiliary therapy and Vitamin supplement for fatigue, Vitamin B＋C nutrient imbalance, and post-operation. Enhance growth, nourish body, and strengthen teeth and Vitamin A＋D weak physical condition. Calcium supplement for pregnant women and postnatal Vitamin D＋Ca women.； Nutrient supplement for growing babies & children, nutrient imbalance, ill or weak physical condition, thermal or consuming patients. Prevent Calcium Deficiency (e.g. osteoporosis, teeth damage, and rickets.) Multi-Vitamins Relieve fatigue and tiredness, strengthen physical vigor. Nutrient supplement for weak physical condition, nutrient imbalance, malnutrition, pregnancy and postnatal period, pre- and post-operation, and malnutrition for children.

（2）Indications for Complex Formulations of Quasi Drug (Category B) Nourish and strengthen weak physical condition and fatigue. Nutrient supplement for ill condition or recovery (physical weakness after ill), loss of appetite (gastrointestinal defects), nutrient imbalance, thermal or consuming diseases, pregnancy or lactation period (or pre- and post-natal period). 20 維生素及礦物質製劑基準草案(英文)-980203

4. Actions (can be chosen to be placed on product insert or label freely)

Ingredient Indication

Vitamin A Improve and help the formation of Rhodopsin, make eyes to adopt light change, and maintain the vision in dark light. Improve and maintain the function of normalization of epithelial tissue and maintain the health of skin and mucous membrane. Improve and help the development and growth of teeth and bone.

β-Carotene Improve and help the formation of Rhodopsin, make eyes to adopt light change, and maintain the vision in dark light. Improve and maintain the function of normalization of epithelial tissue. Improve and help the development and growth of teeth and bone. Vitamin D Improve and enhance the absorption and use of calcium and phosphorous. Help the development and growth of bone and teeth and bone calcification. Improve calcium concentration in the blood and help to maintain the normality. Improve the physical function of nerves and muscles and help to maintain the normality. Vitamin E Improve the oxidation of Polyunsaturated Fatty Acid in the cell membrane, maintain the wholeness of the cell membrane, and possess anti-oxidizing action. Improve and maintain the health of skin and blood cells. Vitamin K Improve and maintain the normal function of blood clotting, activate the clotting proteins in the liver and blood, and combine into substances of prothrombin.

21 維生素及礦物質製劑基準草案(英文)-980203

Ingredient Indication

Vitamin B1 Improve and maintain the function of heart and nervous system. Improve and maintain normal appetite.

Vitamin B2 Improve and maintain skin health.

Pantothenic acid Improve and help the synthesis of body fats and cholesterol and the metabolism of amino acids.

Vitamin B6 Improve and help the metabolism of amino acids. Improve and help the formation of Porphyrin in the red blood cells and maintain the normal size of red blood cells. Improve and maintain the health of nervous system.

Vitamin B12 Improve and help the formation of red blood cells. Improve and maintain the health of red blood cells and nervous system. Vitamin C Improve and help the formation of collagen, combine into the substances of Cytoplasm, and maintain the compactness of cell series. Improve and maintain the growth of connective tissues, bones, and teeth inside the body. Improve and help the absorption of Iron Improve and help the oxidation and reduction inside the body. Nicotinamide ＆ Improve and maintain the health of skin, nervous system, Nicotinic Acid and digestive system. Folic Acid Improve and help the formation of red blood cells. Improve and help the formation of nucleic acid and nucleic protein. Improve and help for normal development and growth of a fetus. Biotin Improve and help the metabolism of energy and amino acids. Improve and help the synthesis of fats and glycogen. Improve and help the synthesis of purine.

22 維生素及礦物質製劑基準草案(英文)-980203

Ingredient Indication

Calcium Improve and maintain the normal contraction of heart and muscles and the sensitivity of nerves. Improve and help the blood clotting and activate the conversion of prothrombin to thrombin. Improve and maintain the health of bones and teeth. Improve and help controlling the cell permeability. Iron Improve and help the formation of red blood cells. As the important substance of composing hemoglobin and myoglobin. Magnesium Improve and maintain the health of bones and teeth. Improve and help the metabolism of carbohydrates and act as energy metabolized factor. Improve and help maintaining the normal function of heart, muscles, and nerves, etc. Iodide Improve and help the synthesis of thyroxine. Improve and help the normal development, growth, and metabolism of nerve and muscle functions. Improve and help adjusting the oxidation of cells. Zinc Improve and help the formation of insulin and poly-enzymes. Improve and help the synthesis of nucleic acid and proteins. Improve and help the metabolism of energy. Phosphorus Improve and help the metabolism of carbohydrates, fats, and proteins. Improve and help the growth and maintenance of bones and teeth. Copper Improve and help the growth and repair of connective tissues. Improve and help the formation of red blood cells. Manganese Improve and help the metabolism of carbohydrates, fats, and proteins. Improve and help the growth and maintenance of bones.

23 維生素及礦物質製劑基準草案(英文)-980203 X. Cautions and Warnings

1. Please store in a cool and dry place and avoid direct sunlight. Please store with caution and keep out of the reach of the children.

2. Vitamin and Mineral supplement is only considered as the supplement for insufficient intake of dietary vitamins and minerals. It can not replace the balanced diet.

3. Before taking this product, please consult a doctor or a pharmacist if you are: (1) Pregnant woman, possibly-pregnant woman, and breast-feeding woman. (2) Patient with hepatic, renal disease, heart disease, or other hypersensitivity.

(3) User as a child.

4. If concomitantly taking other vitamin and mineral supplement or nutritional supplement with this product, please bring along this product and consult a doctor or a pharmacist.

5. Please follow the dose and administration instructions to take this product. Please stop taking this product and consult a doctor or a pharmacist if any discomfort occurred.

6. Please stop taking this product immediately and seek a medical advice if any discomfort or symptoms e.g. skin itches and rashes, nausea, vomiting, or gastrointestinal discomfort symptoms, e.g. flatulence, diarrhea, etc. occurred.

7. Please stop taking this product and consult a doctor or a pharmacist if the symptoms did not get improved after taking this product for over a month. 24 維生素及礦物質製劑基準草案(英文)-980203

8. The product containing oil-soluble vitamins needs to add the warning below ： This product contains oil-soluble vitamins. Do not exceed the recommended dose when taking this product because oil-soluble vitamins easily induce accumulative toxicity.

9. The product containing Vitamin A needs to add the warning below ： This product contains Vitamin A; the pregnant women can not exceed the daily recommended dose.

10. The product containing Vitamin D needs to add the warning below ： This product contains Vitamin D; please consult a doctor or a pharmacist before taking this product if you are a patient with kidney stone, sarcoidosis, or Hyperparathyroidism.

11. The product containing Vitamin E needs to add the warning below ： This product contains Vitamin E; please stop taking this product immediately and seek a medical advice if any discomfort or symptoms e.g. menstruation ahead of time, increased volume of menstruation, or prolonged bleeding time, etc. occurred.

12. The product containing Vitamin K needs to add the warning below ：

This product contains Vitamin K; please pay attention to the following: (1) Please consult a doctor or a pharmacist before taking this product if you take anticoagulant.

25 維生素及礦物質製劑基準草案(英文)-980203

(2) Please consult a doctor or a pharmacist before taking this product if you are a patient with blood clotting problem (e.g. stroke, thrombus, or embolism). (3) Please consult a doctor or a pharmacist before taking this product if you are a patient with serious hepatic function damage.

13. The product containing Vitamin B2 needs to add the warning below ：

This product contains Vitamin B2; the urine will turn bright yellow color after taking Vitamin B2.

14. The product containing minerals needs to add the warning below ： This product contains minerals. Maintenance of adequate mineral balance requires good, balanced diet. The adverse effects caused by long-term intake of high-potency minerals are usually uncertain. Besides, high-potency of single mineral may reduce the bio-availability of other minerals or vitamins.

15. The product containing Calcium needs to add the warning below ： This product contains Calcium. Please only take this product after consulted with a doctor if you are a patient with renal disease or kidney stone. (Excess intake of Calcium may cause kidney stone.

26