MAALOX Oral suspension Ref.[50870] Active ingredients: Aluminium hydroxide Magnesium hydroxide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Product name and form

Maalox 200mg/175mg per 5ml Oral Suspension.

Pharmaceutical Form

Oral Suspension.

White, viscous, aqueous oral suspension with a peppermint odour and taste.

Qualitative and quantitative composition

Each 5 ml of the suspension contains:

200 mg of Magnesium Hydroxide (as Magnesium Hydroxide Paste),
175 mg of Aluminium Hydroxide (as Aluminium Hydroxide Gel).

Excipients: Each 5ml also contains 71.45mg sorbitol (E420) and 1.59mg sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Aluminium hydroxide

Aluminium hydroxide is a slow-acting antacid. It is used to provide symptomatic relief in gastric hyperacidity. In addition, the antipeptic and demulcent activity of aluminium hydroxide helps to protect inflamed gastric mucosa against further irritation by gastric secretions.

Magnesium hydroxide

Magnesium hydroxide is practically insoluble in water and solution is not effected until the hydroxide reacts with hydrochloric acid in the stomach to form magnesium chloride. Its neutralising action is almost equal to that of sodium bicarbonate. When the dose is in excess of that required to neutralise the acid the intragastric pH may reach pH 8 or 9. Acid rebound following magnesium hydroxide is clinically insignificant. Magnesium hydroxide has an indirect cathartic effect resulting from water retention in the intestinal lumen.

List of Excipients

Domiphen bromide
Citric Acid, monohydrate
Saccharin sodium
Sorbitol liquid (Non-crystallising) (E420)
Mannitol (E421)
Hydrogen peroxide
Peppermint oil
Hydrochloric acid
Purified water

Pack sizes and marketing

White PET bottles with plastic screw cap: 250 ml and 355 ml.

Not all pack sizes are marketed.

Marketing authorization holder

Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France

Marketing authorization dates and numbers

PA23180/009/001

Date of first authorisation: 19 April 1982
Date of last renewal: 01 October 2009

Drugs

Drug Countries
MAALOX Austria, Cyprus, Estonia, France, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, Poland, United Kingdom, South Africa

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