Monograph for Vitamin and Mineral Pharmaceutical Products Review and Approval

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 ...
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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.

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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 Active Ingredient

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

10,000 IU

10,000IU



as Vitamin A

10,000 IU

10,000IU



as Vitamin A

Remark *1

Vitamin A*2 Active Ingredient source

β-Carotene *3 Active Ingredient source

Fat Soluble Vitamin

Cod liver oil Retinol Retinol acetate Retinol palmitate Strong cod liver oil Vitamin A fatty acid Ester in oil Vitamin A oil

β-Carotene

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Table I. Active ingredients and their sources Active Ingredient

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

1000 IU

800 IU



as Vitamin D

400 IU

400 IU



as Vitamin E

1mg

500 μg



Remark *1

*4

Vitamin D Active Ingredient source

OTC Drug Daily dosage limitation

Cholecalciferol (Vit. D3) Ergocalciferol (Vit. D2) Ergocalciferol acetate

Vitamin E

*5

d-α-Tocopherol

Fat Soluble Vitamin

Active Ingredient source

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

Vitamin K Active Ingredient source

Phytomenadione (Vit K1, Phylloquinone、Phytonadione) Menaquinone (Vit K2) Menadione (Vit K3) Menadione sodium bisulfite (Vit K3)

Vitamin B1

Active Ingredient source

Water Soluble Vitamin

Benfotiamine (Benzoylthiamine monophosphate) Bisbentiamine(Benzoylthiamine disulfide) Bisibuthiamine Bisthiamine nitrate(Thiamine disulfide nitrate) Cocarboxylase (Thiamine pyrophosphate) Cycothiamine

as Thiamine hydrochloride as Thiamine hydrochloride

250 mg

50 mg

◎ as Thiamine disulfide

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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 as Thiamine hydrochloride

Dicethiamine hydrochloride Fursultiamine Active Ingredient source

as Fursultiamine

Fursultiamine hydrochloride Octotiamine Prosultiamine

250 mg

50 mg



Prothiamine as Thiamine HCl or Thiamine nitrate

Thiamine dicetylsulfate

Thiamine hydrochloride Thiamine nitrate

Vitamin B2 Active Ingredient source

Water Soluble Vitamin

Thiamine disulfide

Riboflavin Riboflavin phosphate Riboflavin phosphate sodium

100 mg

100 mg



1000 mg

500 mg



Riboflavin tetrabutyrate (Riboflavin butyrate)

Pantothenic acid Calcium d-pantothenate Active Ingredient source

Calcium dl-pantothenate d-Panthenol dl-Panthenol Sodium d-pantothenate Sodium dl-pantothenate

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as Riboflavin as Riboflavin

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

200 mg

80 mg



1,000 μg

1,000 μg



2,000 mg

1,000 mg



Remark *1

Vitamin B6

Active Ingredient source

Pyridoxal Pyridoxal hydrochloride Pyridoxal-5-phosphate (calcium salt) Pyridoxal phosphate Pyridoxal phosphate Sodium Pyridoxine Pyridoxine hydrochloride Pyridoxine-5-phosphate Pyridoxamine pyridoxamine-5-phosphate

Cyanocobalamin Active Ingredient source

Water Soluble Vitamin

Vitamin B12 ( Cobalamins) Hydroxocobalamin Hydroxocobalamin acetate

as Hydroxocobal -amin

Hydroxocobalamin hydrochloride Mecobalamin/ Methylcobalamin

Vitamin C Ascorbic Acid Calcium ascorbate Active Ingredient source

Sodium ascorbate L-Ascorbyl Palmitate L-Ascorbyl Steartate Magnesium ascorbate Niacinamide ascorbate Potassium ascorbate

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as Ascorbic Acid

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 Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

500 mg

100mg



Nicotinic Acid、 Niacin

450 mg

100mg



Folic Acid

1,000 μg

800 μg



Biotin Calcium

2500μg

500μg



1800mg

1800mg



Active Ingredient

Remark *1

Nicotinamide Active Ingredient source

Water Soluble Vitamin

Niacinamide Ascorbate

Nicotinamide (Niacinamide)

Active Ingredient source

Mineral

Calcium Oxide Calcium Carbonate Calcium Phosphate Monobasic Calcium Phosphate Dibasic Anhydrou Calcium Phosphate Tribasic Calcium Phosphate Dibasic Calcium Lactate Calcium Gluconolactate 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

as Calcium

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

1800mg

1800mg



Remark *1

Calcium chloride dehydrate Calcium chloride hexahydrate Calcium citrate malate Calcium citrate tetrahydrate Calcium fumarate Calcium glubionate

Active Ingredient source

Mineral

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 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

as Calcium

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

Active Ingredient source

Calcium Hydrogen Phosphate Dihydrate Calcium Hydrogen Phosphate Tricalcium Phosphate Dicalcium Phosphate Calcium Phosphate anhydrous

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

1800mg

1800mg



500μg

200μg



Remark *1

as Calcium

Chromium

Mineral Active Ingredient source

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) 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)

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as Chromium

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

Active Ingredient source

Chromium(III) succinate (chromic succinate) Chromium(III) sulfate(chromic sulfate) Chromic acetate monohydrate Chromic picolinate Niacin bound chromium Chromic nitrate

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

500μg

200μg



Remark *1

as Chromium

Copper Copper oxide Calcium copper edentate

Mineral Active Ingredient source

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) 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)

9mg

Copper(II)malate(cupric malate) 9

8mg



as Copper

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

Active Ingredient source

Copper(II)succinate (Cupric succinate) Copper(II)sulfate (Cupric sulfate) Copper(II)sulfate petahydrate (Cupric sulfate petahydrate)

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

9mg

8mg



as Copper

500μg

195ug



as Iodide

60 mg

22.5 mg



as Iron

Remark *1

Iodine Active Ingredient source

Potassium Iodide Potassium Iodate Sodium Iodide

Mineral

Iron Iron, reduced Ferric Pyrophosphate (iron Pyrophosphate) Iron, Carbonyl Iron, Electrolytic

Active Ingredient source

Ferric Ammonium Citrate Ferric Chloride Ferric Citrate Ferrous Sulfate Ferrous Lactate Iron and Sodium Succinate Citrate Ferric Phosphate Ferrous G1cconate Ferrous Fumarate Iron Lactate Ferrous Bisglycinate Chelate Ferritin Ferrocholinate

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Table I. Active ingredients and their sources Active Ingredient

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

60 mg

22.5 mg



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) Mineral

Active Ingredient source

Ferrous citrate(Iron(II) citrate) Ferrous gluceptate (Iron(II) gluceptate) Ferrous gluconate dehydrate (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

as Iron

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

Active Ingredient source

Ferrous tartrate (Iron(II) tartrate) Ferric glycerophosphate (Iron(II) glycerophosphate)

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

60 mg

22.5 mg



as Iron

600 mg

600 mg



as

Remark *1

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

Mineral

Magnesium fumarate Magnesium gluceptate Magnesium gluconate (Magnesium gluconate dehydrate)

Magnesium

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

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Table I. Active ingredients and their sources Active Ingredient

Active Ingredient source

Magnesium phosphate tribasic tetra-, penta-, or octahydrate (Trimagnesium phosphate tetra-, penta-, or octahydrate) Magnesium phosphate tribasic Magnesium pidolate Magnesium succinate Magnesium sulfate Magnesium sulfate heptahydrate

OTC Drug Daily dosage limitation

Quasi Drug (Category B) Daily dosage limitation

Formul ation Rule

600 mg

600 mg



Remark *1

as

Magnesium

Manganese

Active Ingredient source

Mineral

Manganese(II) bisglycinate (Manganous bisglycinate) Manganese(II) chloride (Manganous chloride) Manganese(II) chloride tetrahydrate(Manganous chloride tetrahydrat e) Manganase(II) citrate (Manganous citrate) Manganese(II) gluconate /Manganous gluconat Manganese(II)glycerophosphate (Manganous glycerophosphate) 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

10 mg

13

9 mg



as

Manganese

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

1800mg

1200 mg



Remark *1

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

as

Phosphorus

Mineral

Sodium phosphate dibasic Sodium phosphate dibasic dodecahydrate Sodium phosphate dibasic hetahydrate Sodium phosphate monobasic Sodium phosphate monobasic dihydrate 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

50 mg

30 mg



as Zinc

Seleniumcysteine Seleniummethionine Sodium selenate Sodium selenite

Zinc Zinc acetate 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

50 mg

30 mg



Remark *1

Zinc bisglycinate Zinc chloride Zinc citrate Zinc fumarate Zinc gluconate Zinc glutarate Zinc glycerate Mineral

Active Ingredient source

Zinc HAP chelate

as Zinc

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)

1μg

=μg RAE

= IU

of Vitamine A

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

All-trans rentinol palmitate

0.55

1.82

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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

1

1.49

d-α-Tocopherol (Natural-Tocopherol)

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.

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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 Vitamin E

Indication 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 & Nicotinic Acid Calcium

Relieve Dermatitis and Nicotinic Acid Deficiency. 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 Vitamin A β-Carotene Vitamin D Vitamin E

Indication Prevent Vitamin A Deficiency (e.g. eye dryness, nyctalopia, etc.) As Vitamin A source to prevent Vitamin A Deficiency (e.g. eye dryness, nyctalopia, etc.) Prevent Vitamin D Deficiency (e.g. Osteomalacia, rickets, etc.) 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

Vitamin B6

Prevent Pantothenic Acid Deficiency. 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 Dermatitis, etc.)

Calcium

Prevent Calcium Deficiency (e.g. Osteomalacia, rickets,

Acid

Deficiency

(symptoms

etc.) Iron

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

19

e.g.

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 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 Vitamin A+D Vitamin D+Ca

Multi-Vitamins

Auxiliary therapy and Vitamin supplement for fatigue, nutrient imbalance, and post-operation. Enhance growth, nourish body, and strengthen teeth and weak physical condition. Calcium supplement for pregnant women and postnatal 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.) 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 preand 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 Vitamin B1

Indication 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.

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維生素及礦物質製劑基準草案(英文)-980203

Ingredient Calcium

Indication 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

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