COFFMUL-LS Drops – Complete Product Information

1. Product Overview

COFFMUL-LS Drops by Amcare Pharmaceuticals is an oral respiratory formulation containing Levosalbutamol Sulphate, Ambroxol Hydrochloride and Guaiphenesin.

According to the supplied product artwork, each 1 mL contains:

• Ambroxol Hydrochloride IP – 7.5 mg

• Guaiphenesin IP – 12.5 mg

• Levosalbutamol Sulphate IP – equivalent to Levosalbutamol 0.25 mg

• Flavoured Syrup Base – Q.S.

The packaging identifies the product as “For Paediatric Use Only” and shows a 15 mL pack with a dropper.

The three ingredients have complementary actions: Levosalbutamol is a bronchodilator, Ambroxol is a mucolytic, and Guaiphenesin is an expectorant. Their roles relate to airway narrowing and the clearance of respiratory mucus.

Important: The composition, paediatric-use wording and 15 mL pack size are taken from the supplied artwork. The artwork does not establish the full approved age range, dose schedule or all authorised indications for this specific product.

2. Product Composition

Product Details

3. What are COFFMUL-LS Drops?

COFFMUL-LS Drops combine three active ingredients that work on different aspects of respiratory symptoms.

Levosalbutamol

A bronchodilator that relaxes airway smooth muscle and helps improve airflow when bronchospasm is present.

Ambroxol Hydrochloride

A mucolytic that helps reduce mucus viscosity and supports the clearance of respiratory secretions.

Guaiphenesin

An expectorant that helps thin mucus in the airways, making it easier to cough up.4. Active Ingredient Profile

A. Levosalbutamol — Equivalent to 0.25 mg per 1 mL

Levosalbutamol belongs to the selective beta-2 adrenergic agonist class of bronchodilators.

Main role: Bronchodilation

It relaxes the smooth muscles surrounding the bronchial airways, helping widen narrowed passages.

Its pharmacological effects may include:

• Improved airflow when bronchospasm responds to treatment

• Relief of wheezing associated with reversible airway narrowing

• Reduction in airway resistance

Levosalbutamol does not directly thin mucus.

Possible adverse effects: Tremor, nervousness, headache, palpitations and a rapid heartbeat.

B. Ambroxol Hydrochloride — 7.5 mg per 1 mL

Ambroxol is a mucolytic medicine used in selected respiratory conditions involving thick or difficult-to-clear mucus.

Main role: Mucus thinning

It helps reduce mucus viscosity and supports the movement of respiratory secretions out of the airways.

Potential roles include:

• Helping loosen thick respiratory secretions

• Supporting mucus clearance

• Making phlegm easier to expectorate

• Supporting the management of selected mucus-producing respiratory conditions

Ambroxol does not act as a bronchodilator.

Precaution: Rare serious allergic and skin reactions have been reported with ambroxol. A progressive rash, blistering or lesions of the mouth or other mucous membranes require prompt medical assessment.

C. Guaiphenesin — 12.5 mg per 1 mL

Guaiphenesin is an expectorant used to help relieve chest congestion.

Main role: Expectorant / Mucus clearance

It helps thin mucus in the air passages so that respiratory secretions can be coughed up more easily.

Potential roles include:

• Helping loosen thick mucus

• Supporting expectoration

• Facilitating the clearance of respiratory secretions

• Helping manage symptoms associated with chest congestion

Guaiphenesin provides symptomatic relief; it does not treat the underlying cause of a respiratory illness.

5. What are COFFMUL-LS Drops Used For?

Based on the pharmacological roles of the ingredients, COFFMUL-LS Drops may be considered for selected respiratory conditions involving mucus congestion and bronchospasm, only where the product is authorised and clinically appropriate.

Productive Cough

Ambroxol and Guaiphenesin support mucus thinning and clearance when thick respiratory secretions are present.

Chest Congestion

The mucolytic and expectorant ingredients support the clearance of difficult-to-clear respiratory secretions.

Wheezing Associated with Bronchospasm

Levosalbutamol relaxes airway smooth muscle and may help improve airflow when bronchospasm responds to treatment.

Selected Respiratory Conditions

The combination’s ingredient profile relates to respiratory conditions involving abnormal mucus and airway narrowing.

Important: These are ingredient-based pharmacological uses, not confirmation of every approved indication for COFFMUL-LS Drops. Its authorised indications must be verified against the current product licence and package insert.

6. How Do COFFMUL-LS Drops Work?

The three ingredients have complementary mechanisms.

Levosalbutamol → Airway Relaxation

Airway smooth-muscle contraction

↓

Beta-2 receptor activation

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Relaxation of bronchial smooth muscle

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Improved airflow when bronchospasm responds to treatment

Ambroxol → Mucus Thinning

Thick respiratory mucus

↓

Reduction in mucus viscosity

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Easier transport of respiratory secretions

↓

Improved mucus clearance

Guaiphenesin → Expectorant Action

Mucus in the respiratory tract

↓

Mucus becomes easier to cough up

↓

Support for expectoration

Combined Action

In simple terms: COFFMUL-LS Drops combine airway-relaxing activity with support for mucus thinning and clearance.

7. Product Highlights

Triple-action respiratory formulation: Contains Levosalbutamol, Ambroxol Hydrochloride and Guaiphenesin.

Bronchodilator action: Levosalbutamol relaxes airway smooth muscle.

Mucolytic action: Ambroxol helps make thick mucus easier to clear.

8. Dosage and Administration

The exact dose and treatment duration must be determined from the approved COFFMUL-LS Drops product information and a healthcare professional’s instructions.

The artwork specifies the strengths per 1 mL but does not provide a complete dosing schedule.

General administration precautions:

• Shake the formulation before use if instructed by the approved label.

• Measure the prescribed quantity accurately with the appropriate dosing device.

• Do not use an ordinary household spoon for precise measurement.

• Follow the prescribed dose, frequency and duration.

• Do not exceed the recommended dose.

• Do not combine with another cough or respiratory medicine without checking its ingredients.

• Seek medical advice if symptoms persist or worsen.

Do not infer a dose for an infant from the concentration alone. The patient’s age, clinical condition and the authorised product instructions must all be considered.

9. Paediatric Safety Information

The artwork states “For Paediatric Use Only.” This is a presentation statement, not proof that the product is suitable for every child or infant.

India’s official standard treatment guideline for children with a common cold states that cough syrups, antihistamines and decongestants are not recommended for routine treatment of that self-limiting condition. The Ministry of Health has also emphasised rational use of cough syrups in children because many coughs resolve without pharmacological treatment.

Before using COFFMUL-LS Drops in a child, confirm:

• The approved minimum age

• The prescribed dose and frequency

• The authorised indication

• Relevant contraindications and precautions

Levosalbutamol may cause tremor, palpitations and a rapid heartbeat.

10. Possible Side Effects

Adverse effects may arise from any of the three active ingredients.

Levosalbutamol-related effects

Possible effects include:

• Tremor or shaking

• Nervousness

• Headache

• Palpitations

• Rapid heartbeat

• Dizziness

• Sleep disturbance

These are recognised adverse effects of levalbuterol medicines.

Ambroxol-related effects

Possible effects include:

• Nausea

• Vomiting

• Gastrointestinal discomfort

• Skin rash

• Hypersensitivity reactions

Rare serious allergic and skin reactions have been reported.

Guaiphenesin-related effects

Possible effects include:

• Nausea

• Vomiting

• Headache

11. Important Safety Information

Cardiovascular Precautions

Because the formulation contains Levosalbutamol, particular caution may be necessary in patients with:

• Heart disease

• Fast or irregular heartbeat

• Hypertension

• Hyperthyroidism

• Diabetes

Levosalbutamol may cause palpitations, tremor and a rapid heartbeat.

Electrolyte Considerations

Beta-2 agonists can lower blood potassium levels in certain clinical situations. The treating clinician should assess relevant risk factors and interacting medicines.

Severe Skin Reactions

Stop treatment and seek prompt medical advice if a progressive rash, blistering or lesions affecting the mouth or other mucous membranes occur during ambroxol treatment.

Respiratory Symptoms

COFFMUL-LS Drops should not be used as a substitute for prescribed emergency treatment for an acute asthma attack or sudden, severe breathing difficulty.

12. Precautions

Medical advice should be obtained before use in patients with:

• Cardiovascular disease

• Hypertension

• Hyperthyroidism

• Diabetes

• Kidney or liver impairment

• A history of peptic ulcer disease

• Known hypersensitivity to any ingredient

• Persistent or unexplained cough

• Chronic respiratory disease requiring ongoing treatment

The exact contraindications and precautions should be verified against the approved COFFMUL-LS Drops package insert.

13. Drug Interaction Considerations

Tell the prescribing healthcare professional about all medicines currently being used.

Other Bronchodilators or Sympathomimetics

Medicines with similar adrenergic activity may increase the risk of tremor, palpitations and other cardiovascular effects.

Beta-blockers

Beta-blockers may oppose the bronchodilator effect of beta-2 agonists and can be problematic in patients with bronchospastic conditions.

Certain Antidepressants

Some medicines, including tricyclic antidepressants and monoamine oxidase inhibitors, may potentiate cardiovascular effects of beta-2 agonists.

Other Cough and Respiratory Medicines

Check other products carefully to avoid unnecessary duplication of bronchodilators, mucolytics or expectorants.

14. When to Consult a Doctor

Medical evaluation is recommended if the patient develops:

• Persistent or worsening cough

• Severe wheezing

• Difficulty breathing

• Chest pain

• Rapid or irregular heartbeat

• Severe dizziness or fainting

• Cough with blood

• Persistent fever

• Severe or rapidly worsening symptoms

• A significant rash, blistering or swelling

Sudden or severe breathing difficulty requires urgent medical attention.

15. Storage and Handling

Store COFFMUL-LS Drops according to the conditions specified on the approved product label.

General precautions include:

• Keep the bottle tightly closed.

• Protect from excessive heat and direct sunlight.

• Keep out of reach of children.

• Check the expiry date before use.

• Do not use if the bottle, seal or dropper is damaged.

• Follow the manufacturer’s instructions for storage after opening.

The exact storage temperature and in-use shelf life should be taken from the approved product information.

16. Packaging Information

The supplied artwork shows:

• Dark pharmaceutical bottle

• Yellow-coloured cap

• White carton with pink and red accents

• Respiratory/lung illustration

• COFFMUL-LS Drops branding

• Dropper-style dosing device

• 15 mL pack

• Amcare branding

The Amcare product listing also identifies COFFMUL-LS Drops as a 15 mL product containing the same three active ingredients and strengths.