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Ambroxol (Tablets, Solution, Syrup, Solvent) Instructions for Use

ATC Code

R05CB06 (Ambroxol)

Active Substance

Ambroxol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Group

Mucolytic expectorant

Pharmacological Action

Mucolytic and expectorant agent, is an active N-demethylated metabolite of bromhexine. It has secretomotor, secretolytic, and expectorant actions. It stimulates the serous cells of the bronchial mucosa, increases the motor activity of the ciliated epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, and enhances the production of endogenous surfactant – a surface-active substance that ensures the sliding of bronchial secretion in the lumen of the airways.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and contributing to a decrease in viscosity and liquefaction of sputum; as a result, mucociliary transport is improved and the removal of sputum from the bronchial tree is facilitated.

Pharmacokinetics

The binding of ambroxol to plasma proteins is approximately 85%. It penetrates the placental barrier and is excreted in breast milk. It is metabolized in the liver to form metabolites (dibromanthranilic acid, glucuronic conjugates), which are excreted by the kidneys. It is excreted mainly by the kidneys – 90% as metabolites, less than 10% unchanged. T1/2 from plasma is 7-12 hours. The T1/2 of ambroxol and its metabolites is approximately 22 hours.

Due to high protein binding and large Vd, as well as slow back penetration from tissues into the blood, significant excretion of ambroxol does not occur during dialysis or forced diuresis. The clearance of ambroxol in patients with severe hepatic impairment is reduced by 20-40%. In severe renal impairment, the T1/2 of ambroxol metabolites is increased.

Indications

Diseases of the respiratory tract with viscous sputum production and difficulty in sputum expectoration in cases where a rapid therapeutic effect is necessary or oral administration of the drug is impossible: acute and chronic bronchitis; pneumonia; bronchial asthma; bronchiectasis; stimulation of surfactant synthesis in respiratory distress syndrome in premature infants and newborns (as part of complex therapy).

ICD codes

ICD-10 code Indication
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J42 Unspecified chronic bronchitis
J44 Other chronic obstructive pulmonary disease
J45 Asthma
J47 Bronchiectasis
P22 Respiratory distress of newborn [distress]
R09.3 Sputum
ICD-11 code Indication
CA20.1Z Chronic bronchitis, unspecified
CA22.Z Chronic obstructive pulmonary disease, unspecified
CA23 Asthma
CA24 Bronchiectasis
CA40.0Z Bacterial pneumonia, unspecified
CA42.Z Acute bronchitis, unspecified
KB23.Z Respiratory disorder of newborn, unspecified
MD10 Abnormal sputum

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.

Tablets, Syrup, Solvent

It is established individually, depending on the indications, clinical situation, patient’s age, and the dosage form used.

Treatment of children under 2 years of age should be carried out only under medical supervision.

Solution

It is established individually, depending on the indications, clinical situation, and the patient’s age.

Adults are prescribed 45 mg/day, 2-3 times/day in divided doses; in severe cases, the dose may be increased to 60-90 mg/day, 2-3 times/day in divided doses; for children, the daily dose is usually 1.2-1.6 mg/kg 2-3 times/day in divided doses.

For respiratory distress syndrome in newborns and premature infants, the daily dose is 30 mg and is usually distributed over 4 separate administrations. For this indication, only specially intended preparations containing Ambroxol should be used.

Adverse Reactions

Allergic reactions rarely – skin rash, urticaria, exanthema, facial edema, dyspnea, itching, fever; frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, skin itching, allergic contact dermatitis.

From the digestive system often – nausea; infrequently – vomiting, diarrhea, dyspepsia, abdominal pain.

From the nervous system often – dysgeusia.

From the skin and subcutaneous tissues very rarely – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome; frequency unknown – acute generalized exanthematous pustulosis.

From the respiratory system often – decreased sensitivity in the oral cavity or pharynx; rarely – dryness of the respiratory mucosa, rhinorrhea; in isolated cases – dryness of the pharyngeal mucosa.

Contraindications

Hypersensitivity to ambroxol or auxiliary components of the preparations; first trimester of pregnancy; lactation period (breastfeeding).

With caution

Impaired bronchial motility and increased mucus secretion (for example, in the rare immotile cilia syndrome); renal failure and/or severe hepatic failure; gastric and duodenal ulcer (including history); second and third trimesters of pregnancy.

Use in Pregnancy and Lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary during the second and third trimesters, the potential benefit of therapy for the mother and the possible risk to the fetus should be assessed.

If it is necessary to use ambroxol during lactation, the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

Use with caution in severe hepatic impairment.

Use in Renal Impairment

Use with caution in renal failure.

Pediatric Use

Can be used in children according to indications, in recommended doses and regimens.

Geriatric Use

Ambroxol can be used in elderly patients according to indications.

Special Precautions

Ambroxol should not be used simultaneously with antitussive drugs that may inhibit the cough reflex, such as codeine, as this may hinder the removal of liquefied sputum from the bronchi.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking Ambroxol are not recommended to perform breathing exercises due to difficulty in expectorating sputum. In severely ill patients, aspiration of liquefied sputum should be performed.

In patients with bronchial asthma, Ambroxol may intensify coughing.

In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – an influenza-like condition may be observed in the early phase: fever, body aches, rhinitis, cough, pharyngitis. With symptomatic therapy, mucolytic agents such as ambroxol hydrochloride may be erroneously prescribed.

Drug Interactions

Antitussives (e.g., codeine) – due to suppression of the cough reflex, accumulation of sputum in the airway lumen with difficulty in its removal is possible (simultaneous use is not recommended).

Amoxicillin, doxycycline, cefuroxime, erythromycin – increased penetration of antibiotics into the bronchial secretion.

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

Rx Only

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

Jivdhara Pharma, Private Limited (India)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 15 mg/5 ml: 50 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Syrup 5 ml
Ambroxol hydrochloride 15 mg

50 ml – dark glass bottles (1) with a measuring cup or spoon – cardboard packs.
100 ml – dark glass bottles (1) with a measuring cup or spoon – cardboard packs.

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 30 mg/5 ml: 50 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Syrup 5 ml
Ambroxol hydrochloride 30 mg

50 ml – dark glass bottles (1) with a measuring cup or spoon – cardboard packs.
100 ml – dark glass bottles (1) with a measuring cup or spoon – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Tablets white, round, flat-cylindrical in shape, with a double-sided bevel and a score on one side.

1 tab.
Ambroxol (as hydrochloride) 30 mg

Excipients: corn starch – 63.6 mg, lactose monohydrate – 138 mg, magnesium stearate – 2.4 mg, colloidal anhydrous silicon dioxide – 6 mg.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, 160 or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate (milk sugar) – 145 mg, corn starch – 9.2 mg, microcrystalline cellulose (MCC-101 Premium) – 9 mg, povidone K25 – 3.8 mg, magnesium stearate – 2 mg, colloidal silicon dioxide – 1 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 (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 15 mg/5 ml: 100 ml bottle

Dosage Form, Packaging, and Composition

Syrup slightly viscous, transparent, colorless, with a raspberry odor.

5 ml
Ambroxol hydrochloride 15 mg

Excipients: benzoic acid – 0.01 g, hyetellose – 0.0075 g, sorbitol – 2.5 g, glycerol – 0.75 g, propylene glycol – 0.15 g, sodium saccharin – 0.0015 g, raspberry flavor – 0.0025 g, water – up to 5 ml.

100 ml – dark glass bottles (1) with a measuring cup or spoon – cardboard packs.
100 ml – polymer bottles (1) with a measuring cup or spoon – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 30 mg/5 ml: 100 ml bottle

Dosage Form, Packaging, and Composition

Syrup slightly viscous, transparent, colorless, with an apricot odor.

5 ml
Ambroxol hydrochloride 30 mg

Excipients: benzoic acid – 0.01 g, hyetellose – 0.0075 g, sorbitol – 2.5 g, glycerol – 0.75 g, propylene glycol – 0.15 g, sodium saccharin – 0.0015 g, apricot flavor – 0.0025 g, water – up to 5 ml.

100 ml – dark glass bottles (1) with a measuring cup or spoon – cardboard packs.
100 ml – polymer bottles (1) with a measuring cup or spoon – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral and inhalation solution 7.5 mg/1 ml: 40 or 100 ml bottle with a measuring cup

Dosage Form, Packaging, and Composition

Solution for oral administration and inhalation colorless or brown, transparent, with a faint characteristic odor.

1 ml
Ambroxol 7.5 mg

Excipients: benzalkonium chloride – 0.225 mg, sodium chloride – 6.22 mg, citric acid – 2 mg, sodium hydrogen phosphate dihydrate – 4.35 mg, water – 989.705 mg.

40 ml – dark glass bottles (1) with a measuring cup – cardboard packs.
40 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.
40 ml – polymer bottles (1) with a measuring cup – cardboard packs.
100 ml – dark glass bottles (1) with a measuring cup – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.
100 ml – polymer bottles (1) with a measuring cup – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

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

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a bevel and a score.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate, potato starch, calcium stearate, colloidal anhydrous silicon dioxide.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Borshchagovsky CPPC NPC, PJSC (Ukraine)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 15 mg/5 ml: 100 ml bottle

Dosage Form, Packaging, and Composition

Syrup 5 ml
Ambroxol hydrochloride 15 mg

100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.

Marketing Authorization Holder

Veltrade, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate (milk sugar), corn starch, microcrystalline cellulose (type 102), povidone K17 (low molecular weight medical polyvinylpyrrolidone 12600±2700), magnesium stearate, colloidal silicon dioxide (aerosil).

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 (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 10, 20, 30, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a bevel.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate – 70.6 mg, corn starch – 35 mg, povidone K17 (low molecular weight polyvinylpyrrolidone) – 3 mg, calcium stearate – 1.4 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 (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 15 mg/5 ml: 100 ml or 200 ml bottle

Dosage Form, Packaging, and Composition

Syrup as a clear, colorless or with a yellowish-brown tint, slightly viscous liquid with a characteristic odor.

5 ml
Ambroxol hydrochloride 15 mg

Excipients: liquid sorbitol (non-crystallizing) – 1750 mg, glycerol (glycerin) – 637.5 mg, flavor “Forest Berries R3712-1” – 11 mg, hyetellose (hydroxyethylcellulose) – 10 mg, benzoic acid – 8.5 mg, acesulfame potassium – 5 mg, flavor “Vanilla with Natural Extract RX15460” – 3 mg, purified water – up to 5 ml.

100 ml – bottles (1) with a measuring cup – cardboard packs.
200 ml – bottles (1) with a measuring cup – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 30 mg/5 ml: 100 ml or 200 ml bottle with a measuring cup

Dosage Form, Packaging, and Composition

Syrup colorless or with a yellowish-brown tint, clear, slightly viscous, with a characteristic odor.

5 ml
Ambroxol hydrochloride 30 mg

Excipients: liquid sorbitol (non-crystallizing) – 1750 mg, glycerol – 637.5 mg, strawberry flavor with natural extract RX9711- 12 mg, hydroxyethylcellulose – 10 mg, benzoic acid – 8.5 mg, acesulfame potassium – 5 mg, flavor “Caramel-Cream 761” – 3 mg, purified water – up to 5 ml.

100 ml – dark glass bottles (1) with a measuring cup – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.
200 ml – dark glass bottles (1) with a measuring cup – cardboard packs.
200 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral solution 15 mg/5 ml: 50 ml or 100 ml bottle or jar with a measuring cup or measuring spoon

Dosage Form, Packaging, and Composition

Oral solution colorless or slightly yellowish, clear or almost clear, viscous, with an apricot odor.

100 ml
Ambroxol hydrochloride 300 mg

Excipients: benzoic acid – 115 mg, glycerol – 10 g, sorbitol – 35 g, hydroxyethylcellulose – 100 mg, apricot flavor – 100 mg, purified water – up to 100 ml.

50 ml – dark glass bottle (1) with a measuring cup or measuring spoon – cardboard packs.
50 ml – polyethylene terephthalate bottles (1) with a measuring cup or measuring spoon – cardboard packs.
50 ml – dark glass jars (1) with a measuring cup or measuring spoon – cardboard packs.
100 ml – dark glass bottle (1) with a measuring cup or measuring spoon – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) with a measuring cup or measuring spoon – cardboard packs.
100 ml – dark glass jars (1) with a measuring cup or measuring spoon – cardboard packs.
50 ml – dark glass bottle (1) (9-300 pcs.) – group packaging (for hospitals) with a measuring cup or measuring spoon.
100 ml – dark glass bottle (1) (9-300 pcs.) – group packaging (for hospitals) with a measuring cup or measuring spoon.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: potato starch – 46.5 mg, lactose monohydrate (milk sugar) – 102 mg, calcium stearate – 1 mg, talc – 0.5 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 (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Lekhim-Kharkiv, CJS (Ukraine)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Ambroxol hydrochloride 30 mg

10 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Makiz-Pharma, LLC (Russia)

Manufactured By

Skopinfarm, LLC (Russia)

Packaging and Quality Control Release

SKOPINFARM, LLC (Russia)

Or

MAKIZ-PHARMA, LLC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Tablets white or almost white, flat-cylindrical, with a bevel.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate – 171 mg, potato starch – 36 mg, talc – 1.8 mg, magnesium stearate – 1.2 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.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral and inhalation solution 7.5 mg/1 ml: 50 ml or 100 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Oral and inhalation solution clear, from colorless to light yellow with a brown tint, odorless.

1 ml
Ambroxol hydrochloride 7.5 mg

Excipients: sodium chloride – 6.22 mg, sodium hydrogen phosphate (sodium hydrogen phosphate dihydrate) – 4.35 mg, citric acid (citric acid monohydrate) – 2 mg, benzalkonium chloride – 0.225 mg, purified water – 989.705 mg.

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) with a dropper cap – cardboard packs.
100 ml – dark glass bottles (1) with a dropper cap – cardboard packs.

A measuring cup or measuring spoon may be included.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a slightly yellowish tint, round, flat-cylindrical, with a bevel and a score.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate – 171 mg, corn starch – 36 mg, magnesium stearate – 1.2 mg, colloidal silicon dioxide (aerosil) – 1.8 mg.

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.
20 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180, 200, 240, or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a score and a bevel.

1 tab.
Ambroxol (as hydrochloride) 30 mg

Excipients: lactose monohydrate – 171 mg, corn starch, colloidal silicon dioxide, magnesium stearate.

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 (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 15 mg/5 ml: 50 ml, 100 ml, 150 ml or 200 ml bottle in a set with a measuring spoon/cup

Dosage Form, Packaging, and Composition

Syrup as a clear yellow liquid with a fruity odor.

5 ml
Ambroxol hydrochloride 15 mg

Excipients: sorbitol (food grade sorbitol), citric acid monohydrate, sodium citrate pentasesquihydrate (trisodium citrate 5.5-hydrate), propylene glycol, riboflavin, Cherry flavor 95, purified water.

50 ml – dark glass bottles (1) in a set with a measuring spoon/cup – cardboard packs.
100 ml – dark glass bottles (1) in a set with a measuring spoon/cup – cardboard packs.
150 ml – dark glass bottles (1) in a set with a measuring spoon/cup – cardboard packs.
200 ml – dark glass bottles (1) in a set with a measuring spoon/cup – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Tablets 30 mg: 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a double-sided bevel and a score on one side.

1 tab.
Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate, potato starch, microcrystalline cellulose 101, magnesium stearate.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral and inhalation solution 7.5 mg/1 ml: 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml or 100 ml bottle

Dosage Form, Packaging, and Composition

Oral and inhalation solution clear, colorless or with a brownish tint, with a faint characteristic odor.

1 ml
Ambroxol hydrochloride 7.5 mg

Excipients: benzalkonium chloride – 0.225 mg, sodium chloride – 6.22 mg, citric acid (anhydrous) – 2 mg, sodium hydrogen phosphate dihydrate – 4.35 mg, water – 989.705 mg.

10 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
20 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
30 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
40 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
50 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
60 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
70 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
80 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
90 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.
100 ml – bottles (1) with a dropper/dropper cap or without it – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Forms

Bottle OTC Icon Ambroxol Oral solution 15 mg/5 ml: 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, 100 ml, 120 ml, 150 ml, or 200 ml bottle
Oral solution 30 mg/5 ml: 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, 100 ml, 120 ml, 150 ml, or 200 ml bottle

Dosage Form, Packaging, and Composition

Oral solution as a clear or almost clear, colorless or almost colorless with a yellowish tint, slightly viscous liquid with a wild berry odor.

5 ml
Ambroxol hydrochloride 15 mg

Excipients: benzoic acid – 8.5 mg, hyetellose (hydroxyethylcellulose) – 10 mg, acesulfame potassium – 5 mg, sorbitol (solution) – 1750 mg, glycerol 85% – 750 mg, wild berry flavor – 11 mg, vanilla flavor – 3 mg, purified water – up to 5 ml.

50 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
60 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
70 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
80 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
90 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
100 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
120 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
150 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
200 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.


Oral solution as a clear or almost clear, colorless or almost colorless with a yellowish tint, slightly viscous liquid with a wild berry odor.

5 ml
Ambroxol hydrochloride 30 mg

Excipients: benzoic acid – 8.5 mg, hyetellose (hydroxyethylcellulose) – 10 mg, acesulfame potassium – 5 mg, sorbitol (solution) – 1750 mg, glycerol 85% – 750 mg, wild berry flavor – 11 mg, vanilla flavor – 3 mg, purified water – up to 5 ml.

50 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
60 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
70 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
80 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
90 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
100 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
120 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
150 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.
200 ml – dark glass bottles (1) in a set with a measuring spoon or measuring cup – cardboard packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral solution 30 mg/5 ml: 100 ml bottle

Dosage Form, Packaging, and Composition

Oral solution as a colorless or almost colorless, clear or almost clear, slightly viscous liquid with a vanilla-strawberry odor.

1 ml
Ambroxol hydrochloride 6 mg

Excipients: benzoic acid – 1.7 mg, hyetellose (hydroxyethylcellulose) – 1.7 mg, acesulfame potassium – 1 mg, sorbitol liquid (non-crystallizing) – 350 mg, glycerol (glycerin) – 150 mg, strawberry flavor – 2.4 mg, vanilla flavor – 0.6 mg, purified water – up to 1 ml.

100 ml – dark glass bottles (1) in a set with a measuring spoon (nominal volume 5 ml) or a measuring syringe, or a measuring cup – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Forms

Bottle OTC Icon Ambroxol Oral solution 15 mg/5 ml: 100 ml or 200 ml bottle
Oral solution 30 mg/5 ml: 100 ml or 200 ml bottle

Dosage Form, Packaging, and Composition

Oral solution as a clear or almost clear, colorless or almost colorless, slightly viscous liquid with a strawberry odor.

5 ml
Ambroxol (as ambroxol hydrochloride) 15 mg

Excipients: sorbitol 70% (sorbitol liquid non-crystallizing), glycerol (glycerin), benzoic acid, hydroxyethylcellulose (hyetellose), acesulfame potassium, strawberry flavor*, purified water.

*The strawberry flavor contains: flavoring substances, natural flavoring substances, propylene glycol (E1520).

100 ml – dark glass bottlesx (1) in a set with a measuring spoon – cardboard packs.
200 ml – dark glass bottlesx (1) in a set with a measuring spoon – cardboard packs.

x with first opening control


Oral solution as a clear or almost clear, colorless or almost colorless, slightly viscous liquid with a strawberry odor.

5 ml
Ambroxol (as ambroxol hydrochloride) 30 mg

Excipients: sorbitol 70% (sorbitol liquid non-crystallizing), glycerol (glycerin), benzoic acid, hydroxyethylcellulose (hyetellose), acesulfame potassium, strawberry flavor*, purified water.

*The strawberry flavor contains: flavoring substances, natural flavoring substances, propylene glycol (E1520).

100 ml – dark glass bottlesx (1) in a set with a measuring spoon – cardboard packs.
200 ml – dark glass bottlesx (1) in a set with a measuring spoon – cardboard packs.

x with first opening control

Marketing Authorization Holder

Pharmtekhnologiya LLC (Republic of Belarus)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 30 mg/5 ml: 100 ml or 150 ml bottle

Dosage Form, Packaging, and Composition

Syrup 5 ml
Ambroxol hydrochloride 30 mg

100 ml – plastic bottles (1) in a set with a dosing cup – cardboard packs.
150 ml – plastic bottles (1) in a set with a dosing cup – cardboard packs.

Marketing Authorization Holder

Pharmtekhnologiya LLC (Republic of Belarus)

Dosage Form

Bottle OTC Icon Ambroxol Syrup 15 mg/5 ml: 100 ml or 150 ml bottle

Dosage Form, Packaging, and Composition

Syrup 5 ml
Ambroxol hydrochloride 15 mg

100 ml – plastic bottles (1) in a set with a dosing cup – cardboard packs.
150 ml – plastic bottles (1) in a set with a dosing cup – cardboard packs.

Marketing Authorization Holder

Flora Kavkaza, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral solution [with apricot flavor] 30 mg/5 ml: fl. 100 ml 1 pc.

Dosage Form, Packaging, and Composition

Oral solution [with apricot flavor] as a slightly viscous, clear, colorless or yellowish liquid with an apricot odor.

5 ml
Ambroxol hydrochloride 30 mg

Excipients: sorbitol 70% – 2500 mg, glycerol (glycerin) – 750 mg, propylene glycol – 150 mg, benzoic acid – 10 mg, hydroxyethylcellulose – 7.5 mg, food flavor “Apricot” – 2.5 mg, sodium saccharin – 1.5 mg, purified water – up to 5 ml.

100 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Flora Kavkaza, JSC (Russia)

Manufactured By

Ven Petrochem & Pharma, Pvt. Ltd (India)

Or

Kores, Ltd (India)

Or

Shilpa Medicare, Ltd (India)

Or

Flora Kavkaza, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Syrup, with raspberry scent 30 mg/5 ml

Dosage Form, Packaging, and Composition

Syrup, with raspberry scent

5 ml
Ambroxol 30 mg

100 ml – polymer bottles – cardboard packs (1 pc.) /100 g in polymer bottles made of polyethylene terephthalate in a set with polymer caps made of polyethylene, or in polymer bottles made of PET, or HDPE, or LDPE in a set with polyethylene closure means, or in polymer bottles made of PET or high or low density polyethylene type FL in a set with high density polyethylene plugs and polymer caps made of high or low density polyethylene or polypropylene, or in polymer bottles made of polyethylene in a set with polyethylene closure means. A label made of label paper or writing paper, or a self-adhesive label is affixed to each bottle. Each bottle together with the instructions for medical use is placed in a cardboard pack. It is allowed to apply the text of the instructions for medical use on the pack/ – Over-the-counter
100 ml – glass bottles – cardboard packs (1 pc.) /100 g in glass bottles, sealed with plugs and caps made of polyethylene, or polymer plugs made of polyethylene and screw-on polymer caps made of polyethylene, or screw polymer caps made of polyethylene, or aluminum caps. A label made of label paper or writing paper, or a self-adhesive label is affixed to each bottle. Each bottle together with the instructions for medical use is placed in a cardboard pack. It is allowed to apply the text of the instructions for medical use on the pack/ – Over-the-counter

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral and inhalation solution 7.5 mg/ml: 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, or 90 ml bottle

Dosage Form, Packaging, and Composition

Oral and inhalation solution colorless, clear or with a yellowish tint, with a faint characteristic odor.

1 ml
Ambroxol 7.5 mg

Excipients: benzalkonium chloride – 0.225 mg, sodium chloride – 6.22 mg, citric acid – 2 mg, sodium hydrogen phosphate dihydrate – 4.35 mg, water – 989.705 mg.

10 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
20 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
30 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
40 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
50 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
60 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
70 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
80 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.
90 ml – bottles – cardboard packs in a set with a measuring spoon or with a measuring cup.

Marketing Authorization Holder

Khimpharm, JSC (Kazakhstan)

Dosage Form

Bottle Rx Icon Ambroxol Solution for intravenous administration 15 mg/2 ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless or slightly colored.

1 ml
Ambroxol hydrochloride 7.5 mg

Excipients: citric acid monohydrate – 1.8 mg, sodium chloride – 13.6 mg, sodium hydrogen phosphate heptahydrate – 4.7 mg, hydrochloric acid 1M – to pH 4.3-5.3, water for injection – up to 2 ml.

2 ml – ampoules of light-protective glass (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules of light-protective glass (10) – contour cell packaging (1) – cardboard packs.

Marketing Authorization Holder

Erkapharm, JSC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral and inhalation solution 7.5 mg/ml: 1 pc. bottle

Dosage Form, Packaging, and Composition

Oral and inhalation solution transparent, colorless or with a yellowish tint, with a weak characteristic odor.

1 ml
Ambroxol hydrochloride 7.5 mg

Excipients: benzalkonium chloride – 0.225 mg, sodium chloride – 6.22 mg, anhydrous citric acid – 2 mg, sodium hydrogen phosphate dihydrate – 4.35 mg, purified water – up to 1 ml.

100 ml – dark glass bottle (1) – cardboard packs.

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Oral solution 15 mg/5 ml: 50 ml, 100 ml, 150 ml or 200 ml bottle

Dosage Form, Packaging, and Composition

Oral solution transparent or almost transparent, colorless or slightly yellowish with a fruity odor.

5 ml
Ambroxol hydrochloride 15 mg

Excipients: benzoic acid – 5.75 mg, glycerol – 500.00 mg, sorbitol – 1750.00 mg, hydroxylethylcellulose – 5.00 mg, fruit flavor (food flavoring essence) – 5.00 mg, purified water – up to 5 ml.

50 ml – orange glass bottles – cardboard packs.
50 ml – polymer bottles – cardboard packs.
100 ml – orange glass bottles – cardboard packs.
100 ml – polymer bottles – cardboard packs.
150 ml – orange glass bottles – cardboard packs.
150 ml – polymer bottles – cardboard packs.
200 ml – orange glass bottles – cardboard packs.
200 ml – polymer bottles – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Ambroxol Renewal Oral and inhalation solution 7.5 mg/1 ml: 4 ml dropper tubes 10 pcs. with or without solvent or 15 pcs., 50 ml or 100 ml bottle with dropper cap and a measuring cup

Dosage Form, Packaging, and Composition

Oral and inhalation solution colorless or brownish, transparent, with a weak characteristic odor.

1 ml
Ambroxol hydrochloride 7.5 mg

Excipients: sodium chloride – 6.22 mg, sodium hydrogen phosphate dihydrate – 4.35 mg, citric acid monohydrate – 2 mg, benzalkonium chloride – 0.225 mg, purified water – up to 1 ml.

Solvent: sodium chloride solution 0.9% – 4 ml (dropper tubes).

4 ml – dropper tubes (10) in a set with solvent (dropper tubes 4 ml 10 pcs.) – cardboard packs.
4 ml – dropper tubes (10) – cardboard packs.
4 ml – dropper tubes (15) – cardboard packs.
50 ml – dark glass bottles with a dropper cap (1), in a set with a measuring cup – cardboard packs.
100 ml – dark glass bottles with a dropper cap (1), in a set with a measuring cup – cardboard packs.

Table of Contents

TABLE OF CONTENTS