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Vitrum® Junior Plus (Chewable tablets) Instructions for Use

Marketing Authorization Holder

Takeda Pharmaceuticals, LLC (Russia)

Manufactured By

Eagle Nutritionals Inc. (USA)

For

TAKEDA PHARMACEUTICALS INTERNATIONAL, AG (Switzerland)

Labeled By

UNIPHARM, Inc. (USA)

Dosage Form

Bottle OTC Icon Vitrum® Junior Plus Chewable tablets: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Product Composition

Chewable tablets weighing 1740 mg.

1 tab. % of the recommended daily intake**
Children 7-11 years Boys 11-14 years Girls 11-14 years
Retinyl acetate (vit. A) 0.466 (0.419-0.699) mg 66 (60-100)% 47 (42-70)% 58 (52.5-87)%
Colecalciferol (vit. D3) 6.6 (6-9.9) mcg 66 (60-99)% 66 (60-99)% 66 (60-99)%
Tocopherol acetate (vit. E) 8.9 (8-13.4) mg TE 89 (80-134)%* 74.2 (66.7-111.7)%* 74.2 (66.7-111.7)%*
Ascorbic acid (vit. C) 80 (72-120) mg 133 (120-200)%* 114 (103-171)%* 133 (120-200)%*
Thiamine mononitrate (vit. B1) 1.466 (1.319-2.199) mg 133 (120-200)%* 113 (101-169)%* 113 (101-169)%*
Riboflavin (vit. B2) 1.6 (1.44-2.4) mg 133 (120-200)%* 107 (96-160)%* 107 (96-160)%**
Pyridoxine hydrochloride (vit. B6) 2 (1.8-3) mg 133 (120-200)%* 118 (106-176)%* 125 (112.5-187.5)%*
Cyanocobalamin (vit. B12) 2.6 (2.4-3.9) mcg 130 (120-195)%* 87 (80-130)%* 87 (80-130)%*
Niacinamide 20 (18-30) mg 133 (120-200)%* 111 (100-167)%* 111 (100-167)%*
Phytomenadione (vit. K1) 10 (9-16) mcg 17 (15-27)% 12.5 (11-20)% 14 (13-23)%
Pantothenic acid (as calcium pantothenate, vit. B5) 4 (3.6-6) mg 133 (120-200)%* 114 (103-171)%* 114 (103-171)%*
Folic acid 0.266 (0.24-0.399) mg 133 (120-200)%* 67-89 (60-133)%* 67-89 (60-133)%*
Biotin 26 (23.4-39) mcg 130 (117-195)%* 104 (93-156)%* 104 (93-156)%*
Calcium 160 (144-200) mg 14.5 (13-18)% 13 (12-17)% 13 (12-17)%
Magnesium 45 (40.5-56.2) mg 18 (16-22)% 15 (13.5-19)% 15 (13.5-19)%
Zinc 8 (7.2-10) mg 80 (72-100)% 67 (60-83)% 67 (60-83)%
Iodine 75 (67.5-120) mcg 62.5 (56-100)% 58 (52-92)% 50 (45-80)%
Iron 9.6 (8.64-12) mg 80 (72-100)% 80 (72-100)% 64 (58-80)%
Copper 0.56 (0.504-0.7) mg 80 (72-100)% 70 (63-87.5)% 70 (63-87.5)%
Manganese 1 (0.9-1.25) mg 50 (45-62.5)%*** 50 (45-62.5)%*** 50 (45-62.5)%***

* does not exceed the upper tolerable intake level;
** according to MR 2.3.1.2432-08 “Norms of physiological requirements for energy and nutrients for various population groups of the Russian Federation”;
*** % of the adequate intake level according to the “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Chapter II, section 1, Appendix 5).

Composition brown sugar, calcium phosphate, acidity regulator citric acid, vitamin C (Ascorbic acid, sodium ascorbate), magnesium oxide, Niacinamide, stabilizer magnesium stearate, stabilizer silicon dioxide, iron fumarate, carrier microcrystalline cellulose, vitamin E (Tocopherol acetate), stabilizer stearic acid, natural orange flavor (maltodextrin, natural orange flavor, acidity regulator citric acid, antioxidant butylated hydroxytoluene), zinc oxide, vitamin B6 (Pyridoxine hydrochloride), vitamin B2 (Riboflavin), vitamin B5 (calcium pantothenate), vitamin B1 (Thiamine mononitrate), vitamin A (Retinyl acetate), Folic acid, vitamin D3 (Colecalciferol), manganese sulfate, Biotin, natural pineapple flavor (dextrose, natural pineapple flavor, stabilizer silicon dioxide), vitamin K1 (Phytomenadione), copper carbonate, potassium iodide, colorant yellow iron oxide, vitamin B12 (Cyanocobalamin).

30 pcs. – polyethylene bottles (1) – cardboard boxes.
60 pcs. – polyethylene bottles (1) – cardboard boxes.
90 pcs. – polyethylene bottles (1) – cardboard boxes.

Therapeutic Category

Dietary supplement – additional source of vitamins and trace elements

Properties

Dietary supplement to reduce the risk of developing hypovitaminosis and mineral deficiency in children aged 7 to 14 years.

Scope of Application

Of the Vitrum® Junior Plus product

As a dietary supplement

  • To compensate for the deficiency of vitamins and minerals in children 7-14 years old;
  • To support proper growth and development of the child;
  • To strengthen the body’s defenses during the cold season;
  • To maintain the functional state of the nervous system during the period of adaptation to school and high psycho-emotional stress.

ICD codes

ICD-10 code Indication
E50-E64 Other types of nutritional deficiencies (E50-E64)
Z54 Convalescence
Z73.0 Burn-out
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
5B7Z Malnutrition, unspecified
QB7Z Convalescence, unspecified
QD85 Burn-out
QE01 Stress, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Children from 4 to 7 years old – 1 chewable tablet per day with meals. The duration of intake is 2-3 weeks. If necessary, the course can be repeated after one month.

Contraindications

  • Individual intolerance to the components of the product;
  • Carbohydrate metabolism disorders.

Special instructions

Dietary supplement, not a medicinal product.

It is recommended to consult a pediatrician before use.

Children with thyroid diseases require consultation with an endocrinologist.

Storage Conditions

The product should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F) and relative air humidity not exceeding 60%.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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