Mixtura sicca contra tussim pro infantibus (Powder) Instructions for Use
ATC Code
R05CA10 (Expectorants in combination)
Clinical-Pharmacological Group
Herbal preparation with expectorant effect
Pharmacotherapeutic Group
Herbal expectorant
Pharmacological Action
A combined preparation that has expectorant, antitussive, and anti-inflammatory effects.
Sodium bicarbonate shifts the pH of bronchial mucus to the alkaline side, reducing the viscosity of sputum; licorice root and anise oil have anti-inflammatory and antispasmodic effects; Sodium benzoate and Ammonium chloride have an expectorant effect.
It promotes the removal of mucus from the airways during coughing.
Indications
- As an expectorant for respiratory tract diseases accompanied by cough with difficult-to-discharge sputum (including tracheitis, bronchitis, bronchopneumonia).
ICD codes
| ICD-10 code | Indication |
| J04 | Acute laryngitis and tracheitis |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J20 | Acute bronchitis |
| J37 | Chronic laryngitis and laryngotracheitis |
| J42 | Unspecified chronic bronchitis |
| R05 | Cough |
| ICD-11 code | Indication |
| CA05 | Acute laryngitis or tracheitis |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
| MD12 | Cough |
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. |
Powder
Orally, for children: dissolve the contents of 1 sachet in 15 ml (1 tablespoon) of cooled boiled water. Take orally 3-4 times a day after meals: for children under 1 year – 15-25 drops; for children 1-2 years – 40 drops; for children 3-4 years – 1/2 teaspoon (2.5 ml); for children 5-6 years – 3/4 teaspoon (3.75 ml); for children 7-8 years – 1 teaspoon (5 ml); for children 9-12 years – 2 teaspoons (10 ml); for children over 12 years – 1 tablespoon (15 ml). The course of treatment is 2-3 weeks.
Adverse Reactions
Allergic reactions, nausea, vomiting, diarrhea are possible; it may have an irritating effect on the gastric mucosa.
Contraindications
- Hypersensitivity to the components of the drug,
- Acute glomerulonephritis;
- Acute pyelonephritis;
- Pregnancy;
- Breastfeeding period;
- Sucrase/isomaltase deficiency;
- Fructose intolerance;
- Glucose-galactose malabsorption.
Use in Pregnancy and Lactation
Contraindicated during pregnancy and lactation.
Use in Renal Impairment
Contraindicated in acute glomerulonephritis and acute pyelonephritis.
Pediatric Use
Used in children according to indications.
Special Precautions
Effect on the ability to drive vehicles and mechanisms
The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Instructions for patients with diabetes mellitus: the carbohydrate content in a single dose of the drug corresponds to 0.06 XE (Bread Units).
Overdose
To date, no cases of overdose have been reported.
Drug Interactions
Concomitant use with antitussive drugs, as well as with drugs that reduce sputum formation, is not recommended.
Storage Conditions
In a dry place, protected from light, at a temperature not exceeding 25°C (77°F).
After dissolving the dry mixture in water, the resulting solution should be stored at a temperature not exceeding 12°C (53.6°F) in a place protected from light for no more than 2 days. Keep out of reach of children.
Shelf Life
The shelf life is 1.5 years.
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
Powder for oral solution (for children): sachets 1.47 g 10, 20, 50, 100 or 200 pcs., jar 1.47 g
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
 |
Mixtura sicca contra tussim pro infantibus | Powder for oral solution (for children): sachets 1.47 g 10, 20, 50, 100 or 200 pcs., jar 1.47 g |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution (for children) of brownish-gray color with lighter inclusions, heterogeneous, with a characteristic odor; caking is possible; an aqueous solution of the drug (1:10) is brown in color.
| 1 sachet/jar | |
| Extract of Althaea officinalis roots | 0.3 g |
| Extract of Glycyrrhiza roots | 0.075 g |
| Sodium bicarbonate | 0.15 g |
| Sodium benzoate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Common anise seed oil | 0.0037 g |
Excipients: sucrose – 0.7538 g.
1.47 g – heat-sealable sachets (10) – cardboard packs.
1.47 g – heat-sealable sachets (20) – cardboard packs.
1.47 g – heat-sealable sachets (50) – cardboard packs.
1.47 g – heat-sealable sachets (100) – cardboard packs.
1.47 g – heat-sealable sachets (200) – cardboard packs.
1.47 g – polyethylene terephthalate jars (1) – cardboard packs.
1.47 g – polymer jars (1) – cardboard packs.
Powder for oral solution: sachets 1.47 g 10 or 25 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution: sachets 1.47 g 10 or 25 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution in the form of a heterogeneous powder mixture from grayish-brown to brownish-gray with a pinkish tint, with lighter and darker inclusions, with a faint characteristic odor; caking is allowed during storage; an aqueous solution of the drug (1:10) should be brown in color.
| 1 sachet | |
| Dry extract of marshmallow roots (semi-finished product) | 0.3 g, |
| With a content of the sum of reducing monosaccharides in terms of dextrose | 4% |
| Dry extract of licorice | 0.075 g, |
| With a content of glycyrrhizic acid in terms of monoammonium salt of glycyrrhizic acid hydrate and absolutely dry substance | 17% |
| Sodium bicarbonate | 0.15 g |
| Sodium benzoate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Anise oil | 0.0037 g |
Excipients: sucrose (sugar) – 0.75 g.
1.47 g – heat-sealable sachets (10) – cardboard packs.
1.47 g – heat-sealable sachets (25) – cardboard packs.
Powder for oral solution (for children): sachets 1, 3, 6, 10, 20 or 40 pcs.
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution (for children): sachets 1, 3, 6, 10, 20 or 40 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution for children heterogeneous, light yellowish-brownish or brownish-gray in color with white and darker inclusions, with the smell of anise oil, hygroscopic; an aqueous solution (1:10) is yellow-brown or brown in color.
| 1 sachet | |
| Extract of Althaea roots | 0.3 g |
| Extract of Glycyrrhiza glabra roots | 0.075 g |
| Sodium benzoate | 0.15 g |
| Sodium bicarbonate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Common anise seed oil | 0.0037 g |
Excipients: sucrose.
1.47 g – sachets made of combined material (1) – cardboard packs.
1.47 g – sachets made of combined material (3) – cardboard packs.
1.47 g – sachets made of combined material (6) – cardboard packs.
1.47 g – sachets made of combined material (10) – cardboard packs.
1.47 g – sachets made of combined material (20) – cardboard packs.
1.47 g – sachets made of combined material (40) – cardboard packs.
Powder for oral solution: sachets 1.47 g 100, 200 or 600 pcs.
Marketing Authorization Holder
Lumi, LLC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution: sachets 1.47 g 100, 200 or 600 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution in the form of a heterogeneous powder mixture of brownish-gray color with white inclusions, with the smell of anise oil; caking is possible; an aqueous solution of the drug (1:10) is brown in color.
| 1 sachet | |
| Dry extract of marshmallow roots | 0.3 g |
| Dry extract of licorice roots | 0.075 g |
| Sodium bicarbonate | 0.15 g |
| Sodium benzoate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Anise oil | 0.0037 g |
Excipients: sucrose – 0.75 g.
1.47 g – heat-sealable sachets (100) – sealed polyethylene packages (1) – cardboard boxes.
1.47 g – heat-sealable sachets (200) – sealed polyethylene packages (1) – cardboard boxes.
1.47 g – heat-sealable sachets (600) – sealed polyethylene packages (1) – cardboard boxes.
Powder for oral solution: sachets 1.47 g 5, 10, 12, 15, 20, 25, 30, 40, 50, 100, 200, 300 or 600 pcs.
Marketing Authorization Holder
Meligen FP, CJS (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution: sachets 1.47 g 5, 10, 12, 15, 20, 25, 30, 40, 50, 100, 200, 300 or 600 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution in the form of a heterogeneous powder mixture of brownish-gray color with lighter inclusions, with the smell of anise oil; caking is possible; an aqueous solution of the drug (1:10) is brown in color.
| 1 sachet | |
| Dry extract of Althaea officinalis roots | 0.3 g |
| Dry extract of Glycyrrhiza glabra roots | 0.075 g |
| Sodium bicarbonate | 0.15 g |
| Sodium benzoate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Common anise seed oil | 0.0037 g |
Excipients: sucrose – 0.75 g.
1.47 g – sachets (5) – cardboard packs.
1.47 g – sachets (10) – cardboard packs.
1.47 g – sachets (12) – cardboard packs.
1.47 g – sachets (15) – cardboard packs.
1.47 g – sachets (20) – cardboard packs.
1.47 g – sachets (25) – cardboard packs.
1.47 g – sachets (30) – cardboard packs.
1.47 g – sachets (40) – cardboard packs.
1.47 g – sachets (50) – cardboard packs.
1.47 g – sachets (100) – cardboard packs.
1.47 g – sachets (200) – cardboard packs.
1.47 g – sachets (10) – bags.
1.47 g – sachets (20) – bags.
1.47 g – sachets (25) – bags.
1.47 g – sachets (50) – bags.
1.47 g – sachets (100) – bags.
1.47 g – sachets (200) – bags.
1.47 g – sachets (300) – bags.
1.47 g – sachets (600) – bags.
Powder for oral solution: sachets 1.47 g 5 or 10 pcs.
Marketing Authorization Holder
Moscow Pharmaceutical Factory CJS (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution: sachets 1.47 g 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution in the form of a heterogeneous powder mixture of brownish-gray color with white inclusions, with the smell of anise oil; an aqueous solution of the drug (1:10) is brown in color.
| 1 sachet | |
| Dry extract of marshmallow roots | 0.3 g |
| Dry extract of licorice | 0.075 g |
| Sodium bicarbonate | 0.15 g |
| Sodium benzoate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Anise essential oil | 0.0037 g |
Excipients: sucrose (refined sugar) – 0.75 g.
1.47 g – heat-sealable sachets (5) – cardboard packs.
1.47 g – heat-sealable sachets (10) – cardboard packs.
Powder for oral solution (for children): sachets, bottles
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution (for children): sachets, bottles |
Dosage Form, Packaging, and Composition
| Powder for the preparation of oral solution (for children) |
| Extract of Althaea officinalis roots |
| Common anise seed oil |
| Extract of Glycyrrhiza glabra roots |
| Sodium bicarbonate |
| Sodium benzoate |
| Ammonium chloride |
200 ml – children’s milk bottles.
Laminated paper sachets.
Powder for oral solution [for children]: 1.47 g sachet
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro infantibus | Powder for oral solution [for children]: 1.47 g sachet |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral solution (for children) of brownish-gray color with lighter inclusions, heterogeneous, with the smell of anise oil; an aqueous solution of the drug (1:10) is brown in color.
| 1 sachet | |
| Dry extract of marshmallow roots | 0.3 g |
| Dry extract of licorice roots | 0.075 g |
| Sodium bicarbonate | 0.15 g |
| Sodium benzoate | 0.15 g |
| Ammonium chloride | 0.0375 g |
| Anise oil | 0.0037 g |
Excipients: sucrose – up to 1.47 g.
1.47 g – heat-sealable sachets.
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