India Extends Restrictions on Two-Ingredient Medicines for Under-Four Children

The Indian government has added new restrictions to certain children’s medicines.

These medicines contain Chlorpheniramine Maleate and Phenylephrine Hydrochloride.

The new rule applies to every fixed-dose combination containing both ingredients.

The medicines must not be used by children younger than four years old.

Companies must print this warning on the medicine label and inside the package.

They must also include it in advertisements and other promotional information.

The government said the combinations could be risky for very young children.

It also said safer alternatives are available.

Medical experts and the Drugs Technical Advisory Board recommended the decision.