DEFINITION

Oral Rehydration Salts is a dry mixture of Sodium Chloride, Potassium Chloride, Sodium Bicarbonate, and Dextrose (anhydrous). Alternatively, it may contain Sodium Citrate (anhydrous or dihydrate) instead of Sodium Bicarbonate. It may contain Dextrose (monohydrate) instead of Dextrose (anhydrous), provided that the Sodium Bicarbonate or Sodium Citrate is packaged in a separate, accompanying container. It contains the equivalent of NLT 90.0% and NMT 110.0% of the amounts of sodium (Na), potassium (K), chloride (Cl), and bicarbonate (HCO₃) or citrate (C₆H₅O₇) calculated from the labeled amounts of Sodium Chloride, Potassium Chloride, and Sodium Bicarbonate [or Sodium Citrate (anhydrous or dihydrate)]. It contains NLT 90.0% and NMT 110.0% of the labeled amounts of anhydrous dextrose (C₆H₁₂O₆) or dextrose monohydrate (C₆H₁₂O₆·H₂O). It may contain suitable flavors.