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, or ally-taken pharmace utical products. 
2.  If the daily dosage limitation of an in gredient 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 v itamins 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 Vitami n 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 (a lso called as compo und 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 classifi ed as OTC Drug. If the daily 
dosage limitation of any ingredie nt in a product is exceed the 
upper daily dosage limit ation of OTC Drug in Table I, the 
product is classified as Prescription Drug. 
(4) If any ingredient of a produc t is not listed in this Monograph 
Table I, please submit the rele vant 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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
Vitamin A*2
Cod liver oil 
Retinol 
Retinol acetate 
Retinol palmitate 
Strong cod liver oil  
Vitamin A fatty acid Ester in oil 
Active Ingredient source 
Vitamin A oil 10,000 IU 10,000IU ◎ as Vitamin A
β-Carotene *3
Fat Soluble Vitamin Active Ingredient source 
β-Carotene 10,000 IU 10,000IU ○ as Vitamin A
      
 2維生素及礦物質製劑基準草案(英文)-980203 
Table I. Active ingredients and their sources 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Vitamin D ＊4
 Cholecalciferol (Vit. D3) 
 
Ergocalciferol (Vit. D2) 
 Active Ingredient source  Ergocalciferol acetate 1000 IU 800 IU ◎ as Vitamin D
 Vitamin E ＊5
 d-α-Tocopherol 
d-α-Tocopherol acetate 
d-α-Tocopherol succinate 
(d-α-Tocopheryl acid succinate) 
dl-α-Tocopherol 
dl-α-Tocopherol acetate 
dl-α-Tocopherol succinate 
(dl-α -Tocopheryl acid succinate) 
Active Ingredient source  
dl-α-Tocopherol calcium succinate
（account by dl- α- Tocopherol succinate ）400 IU 400 IU ◎ as Vitamin E
Vitamin K 
Phytomenadione (Vit K 1, 
Phylloquinone 、Phytonadione ) 
Menaquinone  (Vit K 2) 
Fat Soluble Vitamin  
Menadione (Vit K 3) 
 Active Ingredient source  Menadione sodium bisulfite 
(Vit K 3) 1mg 500 μg ○  
 Vitamin B 1  
Benfotiamine （Benzoylthiamine 
monophosphate）  as Thiamine 
hydrochloride
Bisbentiamine （Benzoylthiamine 
disulfide）  as Thiamine 
hydrochloride
Bisibuthiamine   
Bisthiamine nitrate（ Thiamine 
disulfide nitrate ）  as Thiamine 
disulfide 
Water Soluble Vitamin  Active Ingredient source  
Cocarboxylase                 
（Thiamine pyrophosphate）   
  Cycothiamine  250 mg 50 mg ◎ 
 
 3維生素及礦物質製劑基準草案(英文)-980203 
Table I. Active ingredients and their sources 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
  Dibenzoyl thiamine   
  Dibenzoyl thiamine hydrochloride  
 Dicethiamine hydrochloride as Thiamine 
hydrochloride
 Fursultiamine  
 Fursultiamine hydrochloride  as 
Fursultiamine
 Octotiamine  
 Prosultiamine  
Prothiamine   
Active Ingredient source  
Thiamine dicetylsulfate  as Thiamine 
HCl or 
Thiamine 
nitrate 
 Thiamine disulfide   
 Thiamine hydrochloride  
 Thiamine nitrate 250 mg 50 mg ◎ 
 
Vitamin B 2  
Riboflavin  
Riboflavin phosphate  as Riboflavin
Riboflavin phosphate sodium  as Riboflavin
Active Ingredient source  Riboflavin tetrabutyrate 
(Riboflavin butyrate) 100 mg 100 mg ◎ 
 
Water Soluble Vitamin  
Pantothenic acid 
 Calcium d-pantothenate  
 Calcium dl-pantothenate  
 d-Panthenol 
 dl-Panthenol 
 Sodium d-pantothenate 
 Active Ingredient source  
Sodium dl-pantothenate 1000 mg 500 mg ◎  
      
 4維生素及礦物質製劑基準草案(英文)-980203 
Table I. Active ingredients and their sources 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Vitamin B 6
 Pyridoxal  
 Pyridoxal hydrochloride  
 Pyridoxal-5-phosphate  
（calcium salt ）  
 Pyridoxal phosphate  
Pyridoxal phosphate Sodium 
Pyridoxine  
Pyridoxine hydrochloride 
Pyridoxine-5-phosphate 
Pyridoxamine 
Active Ingredient source  
pyridoxamine-5-phosphate 200 mg 80 mg ◎  
Vitamin B 12  
( Cobalamins )  
Cyanocobalamin  
Hydroxocobalamin   
Hydroxocobalamin acetate as 
Hydroxocobal
-amin  
Hydroxocobalamin hydrochloride  
Active Ingredient source  
Mecobalamin/ Methylcobalamin 1,000 μg 1,000 μg ◎ 
 
Vitamin C 
Ascorbic Acid 
Calcium ascorbate 
Water Soluble Vitamin  
Sodium ascorbate 
 L-Ascorbyl Palmitate 
 L-Ascorbyl Steartate 
 Magnesium ascorbate  
 Niacinamide ascorbate 
 Active Ingredient source  
Potassium ascorbate 2,000 mg 1,000 mg ◎ as Ascorbic 
Acid 
 5維生素及礦物質製劑基準草案(英文)-980203 
Table I. Active ingredients and their sources 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Nicotinamide 
Niacinamide Ascorbate  
Active Ingredient source  Nicotinamide (Niacinamide) 500 mg 100mg ◎  
Nicotinic Acid 、 Niacin  450 mg 100mg ◎  
Water Soluble Vitamin  
Folic Acid 1,000 μg 800 μg ○  
 Biotin 2500μg 500μ g ○  
Calcium      
Calcium Oxide     
Calcium Carbonate     
Calcium Phosphate 
Monobasic     
Calcium Phosphate 
Dibasic Anhydrou     
Calcium Phosphate 
Tribasic     
Calcium Phosphate 
Dibasic     
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     
Mineral Active Ingredient source  
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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
  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     
Calcium lactate gluconate     
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     
Mineral  Active Ingredient source  
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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Calcium Hydrogen Phosphate 
Dihydrate     
Calcium Hydrogen Phosphate     
Tricalcium Phosphate 1800mg 1800mg ◎ as Calcium
Dicalcium Phosphate     
Active Ingredient source  Calcium Phosphate anhydrous     
Chromium      
 Chromium （III） bisglycinate 
（Chromic bisglycinate ）     
 Chromium （III）chloride 
（chromic chloride ）     
Chromium （III）chloride 
hexahydrate （chromic chloride 
hexahydrate ）     
Chromium （III）citrate（chromic 
citrate）     
Chromium （III）diniconitinate 
（chromic dinicontinate ） 500μg 200μ g ○ as 
Chromium
Chromium （III）-enriched yeast 
（chromic-enriched yeast ）     
Mineral  
Chromium （III）fumarate 
（chromic fumarate ）     
 Chromium （III） glutarate 
（chromic glutarate ）     
 Active Ingredient source  
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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Chromium （III） succinate 
（chromic succinate ）     
 Chromium （III） sulfate（chromic 
sulfate） 500μg 200μ g ○ as 
 Chromic acetate monohydrate    Chromium
Chromic picolinate     
Niacin bound chromium     
Active Ingredient source  
Chromic nitrate     
Copper     
 Copper oxide     
 Calcium copper edentate     
 Copper（II） acetate 
（Cupric acetate ）     
Copper（II）bisglycinate 
（Cupric bisglycinate ）     
Copper（II）carbonate 
（Cupric carbonate ）      
Copper（II）chloride（Cupric 
chloride）     
Copper（II）chloride dehydrate
（Cupric chloride dihydrate）  9mg 8mg ○ as Copper
Copper（II）citrate 
（Cupric citrate ）      
Active Ingredient source  
Copper（II）fumarate 
（Cupric fumarate ）     
Mineral  
 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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Copper（II）succinate 
（Cupric succinate ）      
 Copper（II）sulfate 
（Cupric sulfate ） 9mg 8mg ○ as Copper
 Active Ingredient source
Copper（II）sulfate petahydrate
（Cupric sulfate petahydrate ）      
Iodine      
Potassium Iodide     
Potassium Iodate 500μg 195ug ○ as Iodide  
Active Ingredient source  Sodium Iodide     
Iron     
 Iron, reduced     
 Ferric Pyrophosphate (iron 
Pyrophosphate)     
Iron, Carbonyl     
Iron, Electrolytic     
Ferric Ammonium 
Citrate     
Ferric Chloride 60 mg 22.5 mg ◎ as Iron  
Mineral  
Ferric Citrate     
 Ferrous Sulfate     
 Ferrous Lactate     
 Iron and Sodium 
Succinate Citrate     
 Ferric Phosphate     
 Ferrous G1cconate     
 Active Ingredient source  
Ferrous Fumarate     
  Iron Lactate     
  Ferrous Bis glycinate 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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
  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 ）     
Ferrous citrate （Iron(II) citrate ）     
Ferrous gluceptate 
（Iron(II) gluceptate ）      
Ferrous gluconate dehydrate 
（Iron(II) gluconate dihydrate）  60 mg 22.5 mg ◎ as Iron  
Ferrous glutarate  
（Iron(II) glutarate ）     
Ferrous glycine sulfate  
（Iron(II) glycine sulfate）      
Ferrous lactate trihydrate （Iron(II) lactate trihydrate ）     
Active Ingredient source  
Ferrous malate （Iron(II) malate ）     
Mineral  
 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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Ferrous tartrate  
（Iron(II) tartrate ）     
 Ferric glycerophosphate 
（Iron(II) glycerophosphate ） 60 mg 22.5 mg ◎ as Iron  
 Ferrous fumarate     
 Active Ingredient source  Ferrous Sulfate Dehydrate      
 Magnesium     
  Magnesium acetate     
  Magnesium acetate tetrahydrate     
  Magnesium ascorbate     
  Magnesium aspartate     
  Magnesium bisglycinate     
 Magnesium carbonate     
 Magnesium chloride     
Magnesium chloride hexahydrate     
Magnesium citrate     
Magnesium fumarate     
Magnesium gluceptate 600 mg 600 mg ○ as  
Magnesium gluconate 
(Magnesium gluconate dehydrate)   Magnesium
Magnesium glutarate     
Magnesium glycerophosphate     
Magnesium hydroxide     
Mineral  Active Ingredient source  
Magnesium lactate     
  Magnesium malate     
  Magnesium oxide     
  Magnesium phosphate dibasic trihydrate （Ma
gnesium h ydrogen 
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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Magnesium phosphate tribasic 
tetra-, penta-, or octahydrate（Trimagnesium phosphate tetra-, 
penta-, or octahydrate ）      
 Magnesium phosphate tribasic 600 mg 600 mg ○ as  
 Magnesium pidolate    Magnesium
 Magnesium succinate     
Magnesium sulfate     
Active Ingredient source  
Magnesium sulfate heptahydrate     
Manganese     
Manganese （II） bisglycinate
（Manganous bisglycinate ）     
Manganese （II） chloride
（Manganous chloride ）     
Manganese （II） chloride 
tetrahydrate （Man ganous chloride 
tetrahydrat e ）   
   
Manganase （II） citrate
（Manganous citrate ）     
Manganese （II） gluconate 
/Manganous gluconat     
Manganese （II）glycerophosphate
（Manganous glycerophosphate ）10 mg 9 mg ○ as 
Manganese
Manganese （II）HAP chelate
（Manganous HAP chelate ）      
Manganese （II）HVP chelate
（Manganous HVP chelate ）     
Manganese （II）sulfate
（Manganous sulfate ）      
Manganese （II）sulfate 
monohydrate （Man ganous sulfate 
monohydrate ）   
   
Mineral  
Manganese （II）sulfate 
tetrahydrate （Manganous sulfate 
tetrahydrate ）      
 Active Ingredient source  
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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
 Phosphorus      
  Bone meal （Calcium & Phosphorus 
should be labeled ）     
  Calcium glycerophosphate     
  Calcium phosphate dibasic     
 Calcium phosphate monobasic     
 Calcium phosphate tribasic     
Potassium phosphate dibasic     
Potassium phosphate monobasic 1800mg 1200 mg ○ as  
Sodium phosphate dibasic    Phosphorus
Sodium phosphate dibasic 
dodecahydrate     
Sodium phosphate dibasic 
hetahydrate     
Active Ingredient source  
Sodium phosphate monobasic     
 Sodium phosphate monobasic 
dihydrate     
 Sodium phosphate monobasic 
monohydrate     
 Calcium phosphate dibasic 
（Anhydrous ）     
Selenium     
Monohydrated selenium dioxide     
Selenium citrate     
Selenium HAP chelate     
Selenium HVP chlelate     
Selenium yeast 400μg 200μ g ○ as Selenim
Seleniumcysteine     
Seleniummethionine     
Sodium selenate     
Mineral  Active Ingredient source  
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 
Active Ingredient OTC Drug 
Daily dosage 
limitation Quasi Drug 
(Category B) 
Daily dosage 
limitation Formul
ation 
Rule Remark *1
  Zinc bisglycinate     
  Zinc chloride     
Zinc citrate     
Zinc fumarate     
Zinc gluconate     
Zinc glutarate     
Zinc glycerate     
Zinc HAP chelate 50 mg 30 mg ○ as Zinc  
Zinc HVP chelate     
Zinc malate     
Zinc monomethionine     
Zinc oxide     
Zinc phosphate     
Zinc succinate     
Zinc sulfate     
MineralActive Ingredient source  
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  
of Vitamine A = IU 
of Vitamine A 
All-trans beta-carotene 0.50 1.67 
All-trans rentinol 1.00 3.33 
All-trans rentinol acetate 0.87 2.90 1μg 
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 ＝0.025μ g Cholecalciferol 
                      ＝0.025μg Ergocalciferol  
＊5. Activity of Vitamin E 
 Ingredient (1 mg) ＝mg d-α-Tocopheryl 
Equivalent of Vit E = IU of Vitamin E
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 1 mg 
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 formul ation 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 B 1 Relieve the symptoms of neuritis, neural pain, muscle pain, arthralgia, etc. 
Relieve Beriberi. 
Vitamin B 2 Relieve the symptoms of Stomatitis, Cheilitis, Glossitis, and 
angular Stomatitis, etc. 
Relieve the symptoms of eczema, dermatitis, Acne Vulgaris, 
etc. 
Pantothenic AcidPantothenic Acid deficiency 
Vitamin B 6 Relieve the symptoms of Stomatitis, Cheilitis, Glossitis, and 
Angular Stomatitis, etc. 
Relieve the symptoms of ecze ma, dermatitis, skin macula, 
Urticaria, etc. 
Relieve the symptoms of pregnancy morning sickness, 
nausea, pregnancy uncomfortableness, etc. 
Vitamin B 12 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 Derm atitis, Melasma, Freckle, 
Hyperpigmentation Abnormality, etc. 
Nicotinamide ＆
Nicotinic Acid Relieve Dermatitis and Nicotinic Acid Deficiency. 
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 
Vitamin  A Prevent Vitamin A Deficiency (e .g. eye dryness, nyctalopia, 
etc.) 
β-Carotene  As Vitamin A source to preven t 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 ＆
Nicotinic Acid Prevent Nicotinic Acid De ficiency (symptoms e.g. 
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 Formulatio ns (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 
Vitamin B Complex Nutrient supplement, ill recovery. 
Enhance the growth of babies and children 
Auxiliary therapy for thermal contagious patients. 
Relieve fatigue and tiredness. 
Vitamin B ＋C Auxiliary therapy and Vitami n supplement for fatigue, 
nutrient imbalance, and post-operation. 
Vitamin A ＋D Enhance growth, nourish body , and strengthen teeth and 
weak physical condition. 
Vitamin D ＋Ca Calcium supplement for pregnant women and postnatal 
women.； 
Nutrient supplement for gr owing 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 we ak 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 phy sical condition and fatigue. 
Nutrient supplement for ill condition  or recovery (physical weakness 
after ill), loss of appetite (gastrointe stinal 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 formatio n of Rhodopsin, make eyes 
to adopt light change, and maintain the vision in dark 
light. 
Improve and maintain the func tion 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 fo rmation of Rhodopsin, make eyes 
to adopt light change, and maintain the vision in dark 
light. 
Improve and maintain the func tion of normalization of 
epithelial tissue. 
Improve and help the develo pment and growth of teeth 
and bone. 
Vitamin  D Improve and enhance the abso rption 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 heal th of skin and blood cells. 
Vitamin  K Improve and maintain the no rmal 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 formatio n of Porphyrin in the red  
blood cells and maintain the no rmal size of red blood cells. 
Improve and maintain the he alth 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 formatio n of collagen, combine into 
the substances of Cytopl asm, and maintain the 
compactness of cell series. 
Improve and maintain the grow th 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 ＆
Nicotinic Acid Improve and maintain the heal th of skin, nervous system, 
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 adjustin g the oxidation of cells. 
Zinc Improve and help the fo rmation 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 metaboli sm 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 metaboli sm 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 supplemen t is only considered as the 
supplement for insufficient intake of dietary vitamins and 
minerals. It can not repl ace the balanced diet. 
3. Before taking this product,  please consult a doctor or a 
pharmacist if you are: 
(1) Pregnant woman, poss ibly-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 othe r vitamin and mineral supplement 
or nutritional supplement with th is product, please bring along 
this product and consult a doctor or a pharmacist. 
5. Please follow the dose and admi nistration instructions to take 
this product. Please stop taki ng this product and consult a 
doctor or a pharmacist if any discomfort occurred. 
6. Please stop taking this pro duct immediately and seek a medical 
advice if any discomfort or sympto ms e.g. skin itches and rashes, 
nausea, vomiting, or gastrointest inal discomfort symptoms, e.g. 
flatulence, diarrhea, etc. occurred. 
 247. Please stop taking this pr oduct and consult a doctor or a 
pharmacist if the symptoms did not get improved after taking 
this product for over a month. 維生素及礦物質製劑基準草案(英文)-980203 
8. The product containi ng oil-soluble vitamins needs to add the 
warning below ： 
This product contains oil-soluble vitamins. Do not exceed the 
recommended dose when taking th is product because oil-soluble 
vitamins easily induce accumulative toxicity. 
9. The product containing Vita min 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 Vita min D needs to add the warning 
below ： 
This product contains Vitamin D; please consult a doctor or a pharmacist before taking this pr oduct 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 pati ent 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 pati ent 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 mine rals 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, hi gh-potency of single mineral 
may reduce the bio-availability of other minerals or vitamins. 
15. The product containing Calc ium 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. (Exces s intake of Ca lcium may cause 
kidney stone. 
 
 26