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A reference on parapharmacy in Europe

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Oral rehydration solutions

Oral rehydration solutions (ORS) are simple mixtures of water, glucose and electrolytes used to replace fluid and electrolytes lost through acute diarrhoea, vomiting and excessive sweating. The WHO/UNICEF reduced-osmolarity formula is the global reference.

What ORS are

Oral rehydration solutions are pre-formulated combinations of sodium chloride, potassium chloride, a citrate or bicarbonate buffer, and glucose, reconstituted with potable water before use. The formulation exploits the sodium-glucose co-transport mechanism in the small intestine, which allows continued absorption of fluid and sodium even in conditions where intestinal fluid losses are increased. The WHO/UNICEF "reduced-osmolarity" formula, adopted in 2002, has a total osmolarity of around 245 mOsm/L, lower than earlier ORS formulations; it is currently the standard reference formula recommended by WHO and UNICEF.

Regulatory classification in the EU

ORS sit at the boundary between several regulatory regimes:

Where they are sold

The sale channel for any specific ORS product depends on its regulatory classification under national law:

Intended use

ORS are intended to replace fluid and electrolyte losses. They do not, by themselves, treat the underlying cause of diarrhoea or vomiting. Decisions about whether and how to use ORS in a specific situation — particularly in young children, infants, the elderly and people with underlying chronic conditions — are clinical decisions and require the advice of a pharmacist or a physician. This site does not provide diagnostic, dosing or treatment guidance.

Practical labelling considerations

An ORS package, in any regulatory class, will indicate the intended use, the reconstitution instructions, the composition (typically listing the per-litre concentrations of sodium, potassium, chloride, citrate/bicarbonate and glucose), and the population for whom the product is suitable. Reconstitution with the volume of water indicated is essential to delivering the intended osmolarity and electrolyte concentrations; reconstitution with the wrong volume changes the product and is unsafe.

References & further reading

  1. World Health Organization, "Oral rehydration salts (ORS): a new reduced osmolarity formulation" — WHO/UNICEF position: who.int.
  2. Regulation (EU) No 609/2013 on foods for specific groups, including foods for special medical purposes: eur-lex.europa.eu.
  3. Commission Delegated Regulation (EU) 2016/128 on the specific compositional and information requirements for foods for special medical purposes: eur-lex.europa.eu.

Last reviewed: May 2026.