Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard

Description

This Labelling Standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for single and multiple-ingredient orally administered nonprescription paediatric products for use in children 6 to under 12 years of age to provide relief of symptoms associated with the common cold.

Resources

Name Format Description Link
Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard HTML Open resource
Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard HTML Open resource

Tags

Topics

Categories