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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 Disclaimer

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

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Lumi, LLC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Meligen FP, CJS (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon 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.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon 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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