Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
Alka-Seltzer Effervescent Tablets.
Acetylsalicylic acid (Aspirin) 324mg
Sodium Hydrogen Carbonate 1744mg
Citric acid 965mg
| Pharmaceutical Form |
|---|
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Effervescent tablets (Tablet). White circular tablet – one face flat with bevelled edge; reverse embossed with the name Alka-Seltzer, and a rim. |
Each effervescent tablet contains 324 mg acetylsalicylic acid (Aspirin), 965 mg citric acid and 1744 mg sodium hydrogen carbonate. The active ingredients in water become sodium citrate 1296 mg, sodium acetylsalicylate 364 mg and sodium bicarbonate 328 mg.
Excipient(s) with known effect:
Sodium 477 mg
Sodium benzoate (E211) 0.013 mg
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Acetylsalicylic acid |
Acetylsalicylic acid combines significant advantages such as strong anti-pyretic, analgesic and anti-inflammatory action, that is the measure of comparison with all the newer NSAIDs. |
|
| Citric acid |
Potassium citrate is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, uric acid lithiasis with or without calcium stones. When potassium citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. |
|
| Sodium bicarbonate |
Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. |
| List of Excipients |
|---|
|
Povidone |
Aluminium foil pouches, each containing two tablets. Available in pack sizes of 10 or 20 tablets.
Primary packaging material: composite aluminium foil laminate consisting of 40g/m² paper, 14g/m² polyethylene and 25µm aluminium foil with 18g/m² surlyn heat-seal.
Not all pack sizes may be marketed.
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
PA 1410/32/1
Date of first authorisation: 01 April 1978
Date of latest renewal: 01 April 2008
| Drug | Countries | |
|---|---|---|
| ALKA-SELTZER | Austria, Canada, Germany, Estonia, France, Hong Kong, Ireland, Malta, Mexico, Romania, Singapore, Turkey, United Kingdom, South Africa |
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