Althaeae radices (Syrup, Herbal raw material) Instructions for Use
ATC Code
R05CA05 (Althaea officinalis roots)
Active Substance
Althaeae radix (DAB German Pharmacopoeia)
Clinical-Pharmacological Group
Laxative drug that stimulates intestinal peristalsis
Pharmacotherapeutic Group
Drugs used for cough and colds; expectorants, excluding combinations with antitussives; expectorants
Pharmacological Action
Herbal medicine. Marshmallow root contains plant mucilage (up to 35%), asparagine, betaine, pectin substances, and starch.
It has an enveloping, softening, expectorant, and anti-inflammatory effect.
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, including laryngitis, tracheitis, bronchitis, and bronchial asthma, to provide an enveloping and expectorant effect.
- Gastritis, gastric ulcer, and duodenal ulcer, where the protective plant mucilage film soothes the gastrointestinal mucosa.
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 specific indication, the patient’s age, and the clinical response.
For the syrup and herbal raw material, follow the specific product’s labeled instructions or the prescribing physician’s directions.
Administer the syrup undiluted, followed by a sufficient amount of warm liquid.
Adverse Reactions
Monitor for hypersensitivity reactions.
Discontinue use immediately and institute appropriate therapy if any signs of an allergic reaction, such as skin rash, itching, or urticaria, occur.
Drug Interactions
Be aware that the plant mucilage can form a protective layer on the gastrointestinal mucosa.
This layer may delay or reduce the absorption of concurrently administered oral medications.
Administer other oral drugs at least one hour before or several hours after taking this preparation to avoid a potential interaction.
Contraindications
Do not administer under the following conditions.
- Known hypersensitivity to marshmallow (Althaea officinalis) or any component of the formulation.
- Use in children under 12 years of age due to a lack of sufficient safety and efficacy data for this patient population.
Overdose
No specific antidote is known.
In case of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive treatment.
Gastric lavage may be considered if a large amount was ingested recently.
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 contributes to 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 25°C (77°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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Herbal raw material crushed 35 g: packs
Marketing Authorization Holder
Krasnogorskleksredstva, JSC (Russia)
Dosage Form
 |
Althaeae radices | Herbal raw material crushed 35 g: packs |
Dosage Form, Packaging, and Composition
| Crushed herbal raw material | 1 pack |
| Marshmallow roots | 35 g |
35 g – paper bags (1) – cardboard packs.
Herbal raw material crushed 40 g: packs
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Althaeae radices | Herbal raw material crushed 40 g: packs |
Dosage Form, Packaging, and Composition
| Crushed herbal raw material | 1 pack |
| Marshmallow roots | 40 g |
40 g – Paper bags (1) – cardboard packs.
Herbal raw material crushed 50 g: packs
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Althaeae radices | Herbal raw material crushed 50 g: packs |
Dosage Form, Packaging, and Composition
| Crushed herbal raw material | 1 pack |
| Marshmallow roots | 50 g |
50 g – Paper bags (1) – cardboard packs.
Herbal raw material crushed 75 g: packs
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Althaeae radices | Herbal raw material crushed 75 g: packs |
Dosage Form, Packaging, and Composition
| Crushed herbal raw material | 1 pack |
| Marshmallow roots | 75 g |
75 g – Paper bags (1) – cardboard packs.
Crushed roots 50 g: packs
Marketing Authorization Holder
Health Firm, LLC (Russia)
Dosage Form
|
Althaeae radices | Crushed roots 50 g: packs |
Dosage Form, Packaging, and Composition
| Crushed roots | 1 pack |
| Marshmallow roots | 50 g |
50 g – cardboard packs with an inner bag.
Crushed roots: packs 50 g
Marketing Authorization Holder
Fitofarm PKF, LLC (Russia)
Dosage Form
|
Althaeae radices | Crushed roots: packs 50 g |
Dosage Form, Packaging, and Composition
Crushed roots yellowish-white or grayish-white in color, in the form of pieces of various shapes; odor weak, characteristic; taste of the aqueous extract is sweetish with a sensation of sliminess.
| 1 pack | |
| Marshmallow roots | 50 g |
50 g – cardboard packs with an inner paper bag.
Herbal raw material crushed 35 g: packs
Marketing Authorization Holder
Fito-Em Agrarian And Industrial Firm, CJS (Russia)
Dosage Form
|
Althaeae radix | Herbal raw material crushed 35 g: packs |
Dosage Form, Packaging, and Composition
| Crushed herbal raw material | 1 pack |
| Marshmallow roots | 35 g |
35 g – cardboard packs with inserted polypropylene bags.
Syrup: 50 g, 100 g or 125 g bottle
Marketing Authorization Holder
Begrif, LLC (Russia)
Dosage Form
|
Althaeae sirup | Syrup: 50 g, 100 g or 125 g bottle |
Dosage Form, Packaging, and Composition
Syrup from light yellow to yellow-brown in color, with a weak characteristic odor.
| 100 g | |
| Dry extract of marshmallow roots | 2 g |
Excipients : sucrose (sugar) – 63.3 g, sodium benzoate – 0.38 g, purified water – 34.32 g.
50 g – bottles (1) – cardboard packs.
50 g – bottles 10-200 pcs. – cardboard boxes (for hospitals).
100 g – bottles (1) – cardboard packs.
100 g – bottles 10-200 pcs. – cardboard boxes (for hospitals).
125 g – bottles (1) – cardboard packs.
125 g – bottles 10-200 pcs. – cardboard boxes (for hospitals).
0.9 kg – canisters.
2.7 kg – canisters.
4.5 kg – canisters.
9 kg – canisters.
19 kg – canisters.
20 kg – canisters.
30 kg – canisters.
45 kg – canisters.
Syrup 2 g/100 g: bottle 125 g
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
|
Althaeae sirup | Syrup 2 g/100 g: bottle 125 g |
Dosage Form, Packaging, and Composition
Syrup from light yellow to yellowish-brown in color with a weak characteristic odor.
| 100 g | |
| Dry extract of marshmallow roots | 2 g |
Excipients : sucrose (sugar) – 63.3 g, sodium benzoate – 0.38 g, purified water – 34.32 g.
125 g – dark glass bottles (1) – cardboard packs.
125 g – polyethylene terephthalate bottles (1) – cardboard packs.
Syrup 2 g/100 g: bottle or jar 100 g, 125 g or 200 g
Marketing Authorization Holder
Genel RD, LLC (Russia)
Dosage Form
|
Althaeae sirup | Syrup 2 g/100 g: bottle or jar 100 g, 125 g or 200 g |
Dosage Form, Packaging, and Composition
Syrup from yellowish to yellowish-brown in color, with a weak specific odor.
| 100 g | |
| Dry extract of marshmallow roots* | 2 g |
* containing sucrose – 40%, lactose – 35%, sum of reducing monosaccharides calculated as glucose – 1%.
Excipients : sucrose – 62.72 g, sodium benzoate – 0.38 g, purified water – up to 100 g.
100 g – bottles (1) – cardboard packs.
125 g – bottles (1) – cardboard packs.
200 g – bottles (1) – cardboard packs.
100 g – jars (1) – cardboard packs.
125 g – jars (1) – cardboard packs.
200 g – jars (1) – cardboard packs.
Syrup: bottle or jar 10 g, 15 g, 20 g, 25 g, 30 g, 40 g, 50 g, 90 g, 100 g, 125 g, 150 g, 200 g or 500 g in a set with a dosing spoon or cup
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Althaeae sirup | Syrup: bottle or jar 10 g, 15 g, 20 g, 25 g, 30 g, 40 g, 50 g, 90 g, 100 g, 125 g, 150 g, 200 g or 500 g in a set with a dosing spoon or cup |
Dosage Form, Packaging, and Composition
Syrup in the form of a syrupy liquid from light yellow to yellowish-brown in color, with a characteristic odor.
| 100 g | |
| Extract of marshmallow roots | 1.9 g |
Excipients : sodium benzoate – 0.38 g, sucrose (sugar) – 68.2 g, purified water – 29.52 g.
10 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
15 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
20 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
25 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
30 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
40 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
50 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
90 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
100 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
125 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
150 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
200 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
500 g – bottles in a set with a dosing spoon or cup (1) – cardboard packs.
10 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
15 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
20 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
25 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
30 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
40 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
50 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
90 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
100 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
150 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
200 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
500 g – jars in a set with a dosing spoon or cup (1) – cardboard packs.
Syrup 2 g/100 g: bottle
Marketing Authorization Holder
Flora Kavkaza, JSC (Russia)
Dosage Form
|
Althaeae sirup | Syrup 2 g/100 g: bottle |
Dosage Form, Packaging, and Composition
Syrup from light yellow to yellowish-brown in color, thick; with a characteristic odor.
| 100 g | |
| Dry extract of marshmallow roots | 2 g |
Excipients : sucrose – 62.72 g, sodium benzoate – 0.38 g, purified water – up to 100 g.
100 g – dark glass bottles (1) – cardboard packs.
Syrup 2.5 g/100 g: 95 ml bottle
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Althaeae sirupus-AKOS | Syrup 2.5 g/100 g: 95 ml bottle |
Dosage Form, Packaging, and Composition
Syrup in the form of a thick liquid from light yellow to yellowish-brown in color, with a characteristic odor.
| 1000 ml | |
| Marshmallow root extract (dry extract of Althaea officinalis roots)* | 25 g |
* containing not less than 1% of the sum of reducing monosaccharides calculated as glucose.
Excipients: sodium benzoate, sucrose (white sugar), purified water.
95 ml – bottles made of orange glass with first-opening control and child-resistant closure (1) – cardboard packs.
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