Doktor MOM^® Rubon (Solution) Instructions for Use

Marketing Authorization Holder

Unique Pharmaceutical Laboratories (India)

Company Division

J. B. Chemicals & Pharmaceuticals, Ltd. (India)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Doktor MOM® Rubon

Solution for external use: 10 ml roll-on bottle 1 pc.

Dosage Form, Packaging, and Composition

Solution for external use from colorless to yellow, with a characteristic odor of methyl salicylate.

Excipients: lavender flavor, liquid paraffin.

10 ml – plastic roll-on bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug for external use for colds, cough, headache

Pharmacotherapeutic Group

Local irritant of plant origin

Pharmacological Action

The drug has a local irritant, distracting, and anti-inflammatory effect.

Indications

• Use for symptomatic therapy in the complex treatment of acute respiratory diseases accompanied by cough, rhinitis, feeling of nasal congestion, headache.

ICD codes

Dosage Regimen

Apply externally only. Use for adults and children over 2 years of age.

For rhinitis or nasal congestion, apply the solution several times a day to the skin of the bridge and wings of the nose. Take several deep breaths after application.

For headache, apply to the skin of the temporal region and the skin of the forehead.

Avoid contact with eyes, mucous membranes, and broken skin. Do not apply to the infraorbital area to prevent lacrimation.

Adverse Reactions

Allergic reactions to the components of the drug are possible.

These may include localized skin reactions such as redness, itching, or rash at the application site.

Discontinue use immediately if signs of a severe allergic reaction occur.

Contraindications

• Do not use in case of hypersensitivity to any component of the drug, including levomenthol, camphor, methyl salicylate, or eucalyptus oil.
• Do not apply to damaged skin, including areas with cuts, abrasions, wounds, or skin diseases such as eczema or dermatitis.
• Contraindicated for children under 2 years of age due to the risk of severe adverse reactions.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug can be used after prior consultation with a doctor.

Pediatric Use

Contraindicated in children under 2 years.

Special Precautions

Avoid contact with eyes and mucous membranes.

Do not apply to the skin of the infraorbital area to avoid lacrimation.

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

Overdose

No specific information on overdose is available.

Excessive application may lead to increased local adverse reactions, including severe skin irritation.

In case of accidental ingestion, which is particularly dangerous due to the methyl salicylate content, seek immediate medical attention. Symptoms of salicylate poisoning include nausea, vomiting, tinnitus, and hyperventilation.

Drug Interactions

No clinically significant pharmacokinetic interactions with other drugs have been identified.

Concurrent use with other topical products on the same skin area may increase the risk of local irritation.

Avoid simultaneous application with other topical medications containing methyl salicylate or similar active ingredients to prevent additive effects and potential toxicity.

Storage Conditions

Store in places inaccessible to children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

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.