Monograph for Vitamin and Mineral Pharmaceutical Products...
Transcript of Monograph for Vitamin and Mineral Pharmaceutical Products...
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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(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
Formulation 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 Vitam
in Active Ingredient source
β-Carotene 10,000 IU 10,000IU ○ as Vitamin A
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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
Formulation 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 K1, Phylloquinone、Phytonadione) Menaquinone (Vit K2)
Fat Soluble Vitam
in Menadione (Vit K3)
Active Ingredient source
Menadione sodium bisulfite (Vit K3)
1mg 500 μg ○
Vitamin B1
Benfotiamine (Benzoylthiamine monophosphate)
as Thiamine hydrochloride
Bisbentiamine(Benzoylthiamine disulfide)
as Thiamine hydrochloride
Bisibuthiamine Bisthiamine nitrate(Thiamine disulfide nitrate)
as Thiamine disulfide
Water Soluble V
itamin
Active Ingredient source
Cocarboxylase (Thiamine pyrophosphate)
Cycothiamine
250 mg 50 mg ◎
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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
Formulation 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 B2
Riboflavin Riboflavin phosphate as RiboflavinRiboflavin phosphate sodium as Riboflavin
Active Ingredient source
Riboflavin tetrabutyrate (Riboflavin butyrate)
100 mg 100 mg ◎
W
ater Soluble Vitam
in
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 ◎
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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
Formulation Rule
Remark *1
Vitamin B6
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 B12
( 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 V
itamin
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
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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
Formulation Rule
Remark *1
Nicotinamide
Niacinamide Ascorbate
Active Ingredient source Nicotinamide (Niacinamide)
500 mg 100mg ◎
Nicotinic Acid、 Niacin 450 mg 100mg ◎
Water Soluble V
itamin
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 Dibasic
Calcium Lactate Calcium Gluconolactate 1800mg 1800mg ◎ as CalciumCalcium 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
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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
Formulation 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 CalciumCalcium 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
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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
Formulation Rule
Remark *1
Calcium Hydrogen Phosphate Dihydrate
Calcium Hydrogen Phosphate Tricalcium Phosphate 1800mg 1800mg ◎ as CalciumDicalcium 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 200μg ○ 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)
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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
Formulation Rule
Remark *1
Chromium(III) succinate (chromic succinate)
Chromium(III) sulfate(chromic sulfate)
500μg 200μg ○ as
Chromic acetate monohydrate ChromiumChromic 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)
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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
Formulation 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 M
ineral
Ferric Citrate Ferrous Sulfate Ferrous Lactate Iron and Sodium
Succinate Citrate
Ferric Phosphate Ferrous G1cconate
Active Ingredient source
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
Formulation 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)
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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
Formulation 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(Magnesium hydrogen phosphate trihydrate 、Dimagnesium phosphate trihydrate)
Magnesium phosphate dibasic
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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
Formulation 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(Manganous 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(Manganous sulfate monohydrate)
Mineral
Manganese(II)sulfate tetrahydrate(Manganous sulfate tetrahydrate)
Active Ingredient source
Manganese(IV)oxide
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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
Formulation 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 PhosphorusSodium 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 200μg ○ as SelenimSeleniumcysteine Seleniummethionine Sodium selenate
Mineral
Active Ingredient source
Sodium selenite
Zinc
Zinc acetate 50 mg 30 mg ○ as Zinc
Zinc acetate dihydrate 14
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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
Formulation 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
Mineral
Active 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
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*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
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 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.
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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 &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
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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 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 &Nicotinic Acid
Prevent Nicotinic Acid Deficiency (symptoms e.g. Dermatitis, etc.)
Calcium Prevent Calcium Deficiency (e.g. Osteomalacia, rickets, etc.)
Iron Prevent Iron Deficiency (e.g. Iron Deficiency Anemia)
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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 Auxiliary therapy and Vitamin 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 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).
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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.
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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 &Nicotinic Acid
Improve and maintain the health 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.
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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.
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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.
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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.
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.
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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.
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