Herbelen (Syrup) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

ATC Code

R05CA10 (Expectorants in combination)

Dosage Form

Herbelen

Syrup: bottle or jar 100 ml, 150 ml or 200 ml/with measuring cup or syringe, or spoon

Dosage Form, Packaging, and Composition

Syrup from brown to reddish-brown in color, with a characteristic odor; opalescence is allowed.

Excipients: sucrose, methylparahydroxybenzoate, orange oil.

100 ml – bottles (1) – cardboard packs*
150 ml – bottles (1) – cardboard packs*
200 ml – bottles (1) – cardboard packs*
100 ml – jars (1) – cardboard packs*
150 ml – jars (1) – cardboard packs*
200 ml – jars (1) – cardboard packs*

*may be supplied with a measuring cup, measuring syringe, or measuring spoon.

Clinical-Pharmacological Group

Herbal preparation with expectorant and anti-inflammatory effects

Pharmacotherapeutic Group

Drugs used for cough and colds; expectorants, excluding combinations with antitussives; expectorants

Pharmacological Action

A combined medicinal product.

It has expectorant, anti-inflammatory, antimicrobial (bacteriostatic) action.

Indications

• Use as part of the complex therapy for inflammatory diseases of the upper respiratory tract presenting with a dry cough.
• Use for the symptomatic management of a dry cough in smokers.

ICD codes

Dosage Regimen

Administer orally, 3 to 5 times per day, with the frequency determined by the patient’s age.

For adults and adolescents over 14 years, administer 15 ml per dose.

For children aged 7 to 14 years, administer 10 ml per dose.

For children aged 4 to 6 years, administer 5 ml per dose.

For children aged 2 to 3 years, administer 2.5 ml per dose.

Use only the provided measuring device for accurate dosing.

Shake the bottle well before each use to ensure uniform consistency.

The duration of treatment depends on the clinical situation; do not exceed the recommended daily dosage.

If symptoms persist beyond 7 days, or if high fever, persistent headache, or shortness of breath develops, consult a physician.

Adverse Reactions

Monitor for allergic reactions, including skin rash, itching, and urticaria.

Observe for dyspeptic symptoms such as heartburn. Discontinue use if adverse reactions are severe or persistent.

Contraindications

• Do not use in patients with a known hypersensitivity to any component of the product.
• Contraindicated in children under 2 years of age.
• Avoid use in patients with gastric hypersecretion, hyperacid gastritis, or a peptic ulcer in the acute stage.

Use with caution in children aged 2 to 4 years.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Use is contraindicated in children under 2 years of age.

Use with caution in children aged 2 to 4 years.

Special Precautions

If shortness of breath, fever, or bloody sputum occurs during use, a doctor should be consulted.

Drug Interactions

Avoid concomitant use with antitussive drugs and other agents that reduce sputum formation, as this combination can impede the clearance of liquefied secretions.

Do not use simultaneously with other medicinal products containing ascorbic acid to prevent excessive intake.

Overdose

Symptoms of overdose may include nausea, vomiting, and diarrhea due to excessive intake of ascorbic acid and herbal extracts.

In case of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive care. Gastric lavage may be considered if ingestion is recent.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.