Registered Tanzania · TMDA

Dawakof

Ambroxol Hydrochloride 15 mg/5.26ml

TZ 15 H 0278 Syrup respiratory system INN generic

What it does

Ambroxol is a medication that helps relieve cough and improve breathing by making mucus thinner and easier to clear from the airways.

Commonly used for: cough due to respiratory conditions, chronic bronchitis, asthma

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TZ 15 H 0278
Registration date
2025-08-03
Expiry date
2030-08-02
Status
Registered/Compliant
Active ingredient
Ambroxol Hydrochloride 15 mg/5.26ml
Dosage form
Syrup
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
R02AD - Anesthetics, local
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
625
Manufacturer / MAH
Lincoln Pharmaceuticals
Country of origin
INDIA
Manufacturer location
Lincoln House, B/h, Satyam Complex, Science City Rd, Sola, Ahmedabad, Gujarat 380060, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:50:26 · updated 2026-09-24 03:00:47

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ambroxol is a medication that helps relieve cough and improve breathing by making mucus thinner and easier to clear from the airways.

What it treats

  • cough due to respiratory conditions
  • chronic bronchitis
  • asthma

How it works

It works by breaking down mucus in the lungs, making it easier to cough up and clear from the airways.

Who it's for

Ambroxol is suitable for adults and children over a certain age who have a productive cough or difficulty breathing due to mucus.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ambroxol

BNF-referenced

Ambroxol is a mucolytic agent that facilitates the clearance of mucus from the respiratory tract. It is primarily used to treat respiratory disorders associated with excessive mucus production, such as chronic obstructive pulmonary disease (COPD), asthma, and bronchitis. Ambroxol is known for its ability to thin and loosen mucus, making it easier to expel from the lungs.

Indications

  • Chronic obstructive pulmonary disease (COPD)
  • Asthma
  • Bronchitis
  • Respiratory infections with excessive mucus production

Dosage

Children: For children aged 2 to 5 years, the recommended dose is 15 mg to 30 mg daily, divided into two or three doses. For children aged 6 to 12 years, the recommended dose is 30 mg to 60 mg daily, divided into two or three doses.

Adults: The usual adult dose is 30 mg to 120 mg daily, divided into two or three doses.

Mechanism of action

Ambroxol acts by stimulating the secretion of serous mucus in the respiratory tract, which helps to reduce the viscosity of sputum. This mucolytic action enhances the clearance of mucus, facilitating expectoration. It may also influence the production of surfactant in the lungs, contributing to improved lung function.

Pharmacodynamics

Ambroxol exhibits a dose-dependent effect on mucus viscosity and secretion. By enhancing mucociliary clearance, it aids in reducing airway obstruction and improving respiratory function. The onset of action typically occurs within a few hours after administration, with peak effects observed within 1 to 2 days of treatment.

Pharmacokinetics

Ambroxol is well absorbed after oral administration, with a bioavailability of approximately 70%. It is metabolized primarily in the liver through conjugation and oxidation, resulting in active metabolites. The elimination half-life is about 10 hours, and the drug is excreted predominantly via urine, both as unchanged drug and metabolites.

Contra-indications

  • Hypersensitivity to ambroxol or any of the excipients
  • Severe hepatic impairment
  • Severe renal impairment

Adverse effects

  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Skin reactions (rash, urticaria)
  • Headache
  • Dizziness
  • Dry mouth
  • Anaphylactic reactions (rare)

Interactions

  • Ambroxol may enhance the absorption of other drugs due to its mucolytic properties
  • Caution should be exercised when used with other cough suppressants

Precautions

  • Use with caution in patients with a history of peptic ulcer disease
  • Avoid use in patients with asthma unless prescribed by a healthcare professional
  • Monitor renal and hepatic function in patients with pre-existing conditions

Pregnancy

Ambroxol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data on human pregnancy are limited.

Breast-feeding

Ambroxol is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

Formulations

  • Oral solution
  • Syrup
  • Tablets
  • Effervescent tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: ambroxol

PubChem CID 2132

Molecular formula: C13H18Br2N2O

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.