Mastodon

Mucaltin (Tablets) Instructions for Use

ATC Code

R05CA05 (Althaea officinalis roots)

Active Substance

Althaeae radix (DAB German Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

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

Pharmacological Action

Herbal remedy. Marshmallow root contains plant mucilage (up to 35%), asparagine, betaine, pectin substances, and starch.

It has enveloping, soothing, expectorant, and anti-inflammatory effects.

Plant mucilages cover the mucous membranes with a thin layer that remains on the surface for a long time and protects them from irritation.

As a result, the inflammatory process is reduced and spontaneous tissue regeneration is facilitated.

When acting on the gastric mucosa, the protective effect of the plant mucilage film is more prolonged and effective the higher the acidity of the gastric juice (the viscosity of the plant mucilage increases upon contact with hydrochloric acid).

Indications

Use for the symptomatic treatment of the following conditions:

  • Respiratory tract diseases characterized by difficult-to-clear sputum, including laryngitis, tracheitis, bronchitis, and bronchial asthma.
  • Gastritis and peptic ulcer disease of the stomach and duodenum for mucosal protection.

ICD codes

ICD-10 code Indication
J04 Acute laryngitis and tracheitis
J20 Acute bronchitis
J37 Chronic laryngitis and laryngotracheitis
J42 Unspecified chronic bronchitis
J45 Asthma
K25 Gastric ulcer
K26 Duodenal ulcer
K29 Gastritis and duodenitis
ICD-11 code Indication
CA05 Acute laryngitis or tracheitis
CA0G Chronic laryngitis or laryngotracheitis
CA20.1Z Chronic bronchitis, unspecified
CA23 Asthma
CA42.Z Acute bronchitis, unspecified
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified

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.

Determine the dosage individually based on the clinical indication and patient factors.

Administer tablets orally. For optimal effect, allow the tablet to dissolve slowly in the mouth.

Adjust the frequency and duration of administration according to the therapeutic response and symptom severity.

Adverse Reactions

Monitor for allergic reactions, including skin rash, pruritus, or urticaria.

Discontinue use immediately upon the appearance of any hypersensitivity symptoms.

Report any unexpected or severe adverse events to a healthcare professional.

Drug Interactions

Be aware that the mucilage film formed by the preparation may delay the absorption of other concurrently administered oral medications.

Maintain a minimum interval of 1-2 hours between the administration of this product and any other oral drugs.

No other clinically significant drug interactions have been reported.

Contraindications

Do not use under the following conditions:

  • Known hypersensitivity to the active substance (Althaeae radix) or to any of the excipients in the formulation.
  • History of severe allergic reactions to plants from the Malvaceae family.

Overdose

No specific symptoms of overdose have been reported; however, excessive intake may potentiate the risk of adverse gastrointestinal effects.

In case of suspected overdose, provide symptomatic and supportive care.

Gastric lavage is not indicated due to the demulcent and protective properties of the preparation on the gastric mucosa.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or breastfed infant.

Pediatric Use

Should not be used in children under 12 years of age.

Special Precautions

The formation of a plant mucilage film on the surface of the upper respiratory tract mucosa not only provides a pronounced therapeutic effect but also promotes a longer local action of other drugs.

As an expectorant, marshmallow preparations can be used in combination with sodium bicarbonate.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 12, 18, 20, 24, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets from light gray to brownish-gray in color, round, flat-cylindrical, with inclusions, with a bevel and a score, with a characteristic odor.

1 tab.
Extract of marshmallow officinalis roots (Althea officinalis) 50 mg

Excipients: sodium bicarbonate – 87 mg, tartaric acid – 160 mg, calcium stearate – 3 mg.

6 pcs. – non-cell contour packs (2) – cardboard pack.
6 pcs. – non-cell contour packs (3) – cardboard pack.
6 pcs. – non-cell contour packs (4) – cardboard pack.
6 pcs. – non-cell contour packs (5) – cardboard pack.
10 pcs. – non-cell contour packs – cardboard pack.
10 pcs. – non-cell contour packs (2) – cardboard pack.
10 pcs. – non-cell contour packs (3) – cardboard pack.
10 pcs. – non-cell contour packs (4) – cardboard pack.
10 pcs. – non-cell contour packs (5) – cardboard pack.
10 pcs. – non-cell contour packs (6) – cardboard pack.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light gray to brownish-gray in color with inclusions of a lighter or darker color, round, flat-cylindrical, with a bevel and a score, with a characteristic odor.

1 tab.
Extract of marshmallow officinalis herb 50 mg

Excipients: tartaric acid – 157 mg, sodium bicarbonate – 85 mg, povidone K25 – 5 mg, calcium stearate – 3 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 30, 50, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Extract of marshmallow officinalis root (Althea officinalis) 50 mg

Excipients: sodium bicarbonate.

10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (30) – cardboard packs.
10 pcs. – non-cell contour packs (50) – cardboard packs.
10 pcs. – contour cell packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (30) – cardboard packs.
10 pcs. – contour cell packs (50) – cardboard packs.

Marketing Authorization Holder

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Extract of marshmallow officinalis root (Althea officinalis) 50 mg

Excipients: sodium bicarbonate.

10 pcs. – non-cell contour packs.
10 pcs. – contour cell packs.
30 pcs. – polymer jars.

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Extract of marshmallow officinalis root (Althea officinalis) 50 mg

Excipients: sodium bicarbonate.

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – orange glass jars (1) – cardboard packs.

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from light gray to brownish-gray in color with inclusions, round, flat-cylindrical, with a score and a bevel, with a specific odor.

1 tab.
Extract of marshmallow officinalis herb 50 mg

Excipients: sodium bicarbonate – 86.5 mg, tartaric acid – 158.9 mg, povidone (low molecular weight medical polyvinylpyrrolidone) – 1.6 mg, calcium stearate – 3 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – bottles (1) – cardboard packs.
50 pcs. – bottles (1) – cardboard packs.
30 pcs. – polymer tubes (1) – cardboard packs.
50 pcs. – polymer tubes (1) – cardboard packs.
30 pcs. – cases (1) – cardboard packs.
50 pcs. – cases (1) – cardboard packs.

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

Dosage Forms

Bottle OTC Icon Mucaltin Effervescent tablets (orange flavor) 100 mg: 6, 8, 10, 12, 16, 20, 30, or 40 pcs.
Effervescent tablets (with cranberry flavor) 100 mg: 6, 8, 10, 12, 16, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets from grayish-white to brownish-gray in color, round, flat-cylindrical, with a bevel, with inclusions of light brown and red color, with a characteristic odor.

1 tab.
Extract of marshmallow officinalis herb (mucaltin, dry extract) 100 mg

Excipients: sodium bicarbonate – 640.35 mg, citric acid – 736.08 mg, sorbitol – 336.86 mg, povidone K-30 – 11.43 mg, sodium carbonate – 71.85 mg, sodium saccharin – 17.4 mg, orange flavor* – 38 mg, dye β-carotene** – 8 mg, macrogol 6000 – 40 mg, sodium lauryl sulfate – 0.29 mg.

* composition of orange flavor: orange oil.
** composition of β-carotene dye: β-carotene, modified corn starch, corn starch, corn oil, α-tocopherol, ascorbic acid

2 pcs. – non-cell contour packs (3) – cardboard packs.
2 pcs. – non-cell contour packs (4) – cardboard packs.
2 pcs. – non-cell contour packs (5) – cardboard packs.
2 pcs. – non-cell contour packs (6) – cardboard packs.
2 pcs. – non-cell contour packs (8) – cardboard packs.
2 pcs. – non-cell contour packs (10) – cardboard packs.
2 pcs. – non-cell contour packs (15) – cardboard packs.
2 pcs. – non-cell contour packs (20) – cardboard packs.
10 pcs. – cases (1) – cardboard packs.
10 pcs. – tubes (1) – cardboard packs.

Effervescent tablets from grayish-white to brownish-gray in color, round, flat-cylindrical, with a bevel, with inclusions of light brown color, with a characteristic odor.

1 tab.
Extract of marshmallow officinalis herb (mucaltin, dry extract) 100 mg

Excipients: sodium bicarbonate – 640.35 mg, citric acid – 736.08 mg, sorbitol – 322.86 mg, povidone K-30 – 11.43 mg, sodium carbonate – 71.85 mg, sodium saccharin – 17.4 mg, cranberry flavor* – 60 mg, macrogol 6000 – 40 mg, sodium lauryl sulfate – 0.29 mg.

* composition of cranberry flavor: flavoring substances, propylene glycol.

2 pcs. – non-cell contour packs (3) – cardboard packs.
2 pcs. – non-cell contour packs (4) – cardboard packs.
2 pcs. – non-cell contour packs (5) – cardboard packs.
2 pcs. – non-cell contour packs (6) – cardboard packs.
2 pcs. – non-cell contour packs (8) – cardboard packs.
2 pcs. – non-cell contour packs (10) – cardboard packs.
2 pcs. – non-cell contour packs (15) – cardboard packs.
2 pcs. – non-cell contour packs (20) – cardboard packs.
10 pcs. – cases (1) – cardboard packs.
10 pcs. – tubes (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 20, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets from light gray to brownish-gray in color with inclusions, flat-cylindrical, with a bevel and a score, with a specific odor.

1 tab.
Extract of marshmallow officinalis herb 50 mg

Excipients: sodium bicarbonate – 87 mg, tartaric acid – 160 mg, calcium stearate – 3 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (20) – cardboard packs.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (20) – cardboard packs.

Marketing Authorization Holder

Experimental Plant Of The Ssc Ls Of The Ukrmedprom Association, SC (Ukraine)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Marshmallow root (Althea officinalis) extract 50 mg

Excipients: sodium bicarbonate.

30 pcs. – polypropylene containers (1) – cardboard packs.
10 pcs. – non-cell contour packs (1) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light gray to brownish-gray in color, round, flat-cylindrical, with a bevel and a score, with a characteristic odor; the presence of darker and lighter inclusions is allowed.

1 tab.
Marshmallow herb (Althea officinalis) extract 50 mg

Excipients: sodium bicarbonate, tartaric acid, calcium stearate.

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs (4) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (10) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – plastic bottles (1) – cardboard packs.
50 pcs. – plastic bottles (1) – cardboard packs.

Marketing Authorization Holder

Uralbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 20, 30, 40, 50, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Marshmallow root (Althea officinalis) extract 50 mg

Excipients: sodium bicarbonate.

10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (4) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 10, 30, 50, 100, or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Marshmallow root (Althea officinalis) extract 50 mg

Excipients: sodium bicarbonate.

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – non-cell contour packs (20) – polyethylene bags.
30 pcs. – polymer jars (1).
50 pcs. – polymer jars (1).
100 pcs. – polymer jars (1).

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Mucaltin Dispersible tablets 50 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Dispersible tablets from light gray to brownish-gray in color, with inclusions of lighter and darker color, round, biconvex, with a characteristic blackcurrant odor.

1 tab.
Marshmallow herb (Althea officinalis) extract (mucaltin) 50 mg

Excipients: calcium phosphate dibasic anhydrous (anhydrous calcium hydrogen phosphate) – 219.03 mg, crospovidone (crospovidone CL) – 102.82 mg, tartaric acid – 42.4 mg, blackcurrant flavor* – 5.51 mg, calcium stearate – 4.24 mg.

* Flavor composition: natural flavoring substance, maltodextrin – 62.5%, gum arabic (E414) – 26.5%, triacetin (E1518) – 6.5%.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Marketing Authorization Holder

Khimpharm, JSC (Kazakhstan)

Dosage Form

Bottle OTC Icon Mucaltin Tablets 50 mg: 30, 50, 100, 300, 5000, 8000, or 12000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Marshmallow root (Althea officinalis) extract 50 mg

10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – non-cell contour packs (30) – cardboard packs.
10 pcs. – non-cell contour packs (500) – cardboard boxes.
10 pcs. – non-cell contour packs (800) – cardboard boxes.
10 pcs. – non-cell contour packs (1200) – cardboard boxes.

Marketing Authorization Holder

Aspen Pharma, Pty. Ltd. (India)

Manufactured By

Tyumen Chemical Pharmaceutical Plant, FSUE (Russia)

Dosage Form

Bottle OTC Icon Mucaltin tablets 0.05 g Tablets 50 mg: 10, 30, 50, 100, or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Marshmallow root (Althea officinalis) extract 50 mg

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – non-cell contour packs (30) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS