Vitrum^® Baby (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Vitrum® Baby

Chewable tablets: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets in the shape of animal figures from light gray to orange-gray in color, with small light and dark specks, with a light fruity-vanilla taste and smell.

Excipients: sorbitol – 235.38 mg, cottonseed oil – 40 mg, maltodextrin – 23.4 mg, orange juice – 20 mg, guar gum (E412) – 20 mg, colloidal silicon dioxide – 12 mg, magnesium stearate – 8 mg, citric acid – 5 mg, colorant curcumin (E100) – 2.5 mg, colorant carmine red (E120) – 2.5 mg, flavoring French vanilla – 3.75 mg, sucralose – 1.3 mg, flavoring natural French vanilla – 1.25 mg.

30 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

A balanced complex of 13 vitamins and 11 minerals, corresponding to the child’s daily requirement for vitamins, macro- and microelements. Promotes healthy growth and physical development of the child.

Indications

Prevention of deficiency of vitamins or minerals included in the preparation in children 3-5 years old:

• During periods of intensive growth and development;
• During the recovery period after past illnesses;
• With unbalanced or inadequate nutrition;
• With increased physical and emotional stress.

ICD codes

Dosage Regimen

Administer orally, once daily with a meal to enhance absorption and minimize potential gastrointestinal discomfort.

Chew the tablet thoroughly before swallowing; do not swallow it whole.

The recommended duration of therapy is a continuous course of 2 to 3 months.

Subsequent courses of treatment may be initiated only upon the recommendation of a physician.

Strictly adhere to the prescribed one tablet per day dosage; exceeding this dose is not advised.

This regimen is specifically indicated for children aged 3 to 5 years and is not intended for use in children under 3 years of age.

Adverse Reactions

Possible allergic reactions to the components of the drug.

Contraindications

• Hypervitaminosis A and D;
• Hyperthyroidism;
• Wilson’s disease;
• Children under 3 years of age;
• Hypersensitivity to any of the components of the drug.

Pediatric Use

Not prescribed for children under 3 years of age. Used in children aged 3 to 5 years.

Special Precautions

Do not exceed the recommended dose.

It is possible to stain urine in an intense yellow color, which is not dangerous, because it is due to the presence of riboflavin in the composition of the drug, staining of the stool in a dark color, which is also not dangerous, because it is due to the presence of iron in the composition of the drug.

Overdose

Symptoms: nausea, weakness, gastrointestinal disorders.

In case of accidental overdose, consult a doctor.

Treatment: activated charcoal orally; gastric lavage; symptomatic therapy.

Drug Interactions

It is not recommended to take simultaneously with other drugs containing vitamins A, E, D, Iron and Iodine. This increases the risk of overdose.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.