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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Syrup 15 mg/5 ml: 50 ml or 100 ml bottle
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Dosage Form
| 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.
Syrup 30 mg/5 ml: 50 ml or 100 ml bottle
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Dosage Form
| 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.
Tablets 30 mg: 20, 30 or 50 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
Irbit Chemical Pharmaceutical Plant, JSC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, 160 or 200 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Dosage Form
| 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.
Syrup 15 mg/5 ml: 100 ml bottle
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
| 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.
Syrup 30 mg/5 ml: 100 ml bottle
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
| 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.
Oral and inhalation solution 7.5 mg/1 ml: 40 or 100 ml bottle with a measuring cup
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 20, 30 or 50 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
| 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.
Syrup 15 mg/5 ml: 100 ml bottle
Marketing Authorization Holder
Borshchagovsky CPPC NPC, PJSC (Ukraine)
Dosage Form
| 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.
Tablets 30 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Marketing Authorization Holder
Veltrade, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 10, 20, 30, 50 or 60 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
| 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.
Syrup 15 mg/5 ml: 100 ml or 200 ml bottle
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
| 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.
Syrup 30 mg/5 ml: 100 ml or 200 ml bottle with a measuring cup
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
| 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.
Oral solution 15 mg/5 ml: 50 ml or 100 ml bottle or jar with a measuring cup or measuring spoon
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
| 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.
Tablets 30 mg: 20 pcs.
Marketing Authorization Holder
Lekhim-Kharkiv, CJS (Ukraine)
Dosage Form
| 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.
Tablets 30 mg: 10, 20, 30, 40, or 50 pcs.
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
| 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.
Oral and inhalation solution 7.5 mg/1 ml: 50 ml or 100 ml bottle 1 pc.
Marketing Authorization Holder
Marbiopharm, JSC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 20, 30, 40 or 50 pcs.
Marketing Authorization Holder
Marbiopharm, JSC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180, 200, 240, or 300 pcs.
Marketing Authorization Holder
Rif LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
| 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.
Syrup 15 mg/5 ml: 50 ml, 100 ml, 150 ml or 200 ml bottle in a set with a measuring spoon/cup
Marketing Authorization Holder
Tatkhimpharmpreparaty, JSC (Russia)
Dosage Form
| 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.
Tablets 30 mg: 20, 30, 40 or 50 pcs.
Marketing Authorization Holder
Tatkhimpharmpreparaty, JSC (Russia)
Dosage Form
| 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.
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
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
| 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.
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
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Forms
| 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.
Oral solution 30 mg/5 ml: 100 ml bottle
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
| 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.
Oral solution 15 mg/5 ml: 100 ml or 200 ml bottle
Oral solution 30 mg/5 ml: 100 ml or 200 ml bottle
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Forms
| 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
Syrup 30 mg/5 ml: 100 ml or 150 ml bottle
Marketing Authorization Holder
Pharmtekhnologiya LLC (Republic of Belarus)
Dosage Form
| 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.
Syrup 15 mg/5 ml: 100 ml or 150 ml bottle
Marketing Authorization Holder
Pharmtekhnologiya LLC (Republic of Belarus)
Dosage Form
| 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.
Oral solution [with apricot flavor] 30 mg/5 ml: fl. 100 ml 1 pc.
Marketing Authorization Holder
Flora Kavkaza, JSC (Russia)
Dosage Form
| 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.
Syrup, with raspberry scent 30 mg/5 ml
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
| 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
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
Marketing Authorization Holder
Formula-FR, LLC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
| 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.
Solution for intravenous administration 15 mg/2 ml: amp. 2 ml 5 or 10 pcs.
Marketing Authorization Holder
Khimpharm, JSC (Kazakhstan)
Dosage Form
| 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.
Oral and inhalation solution 7.5 mg/ml: 1 pc. bottle
Marketing Authorization Holder
Erkapharm, JSC (Russia)
Manufactured By
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
| 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.
Oral solution 15 mg/5 ml: 50 ml, 100 ml, 150 ml or 200 ml bottle
Marketing Authorization Holder
Yaroslavl Pharmaceutical Factory, CJSC (Russia)
Dosage Form
| 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.
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
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
| 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.
