Guidance document - Nonprescription oral adult expectorant cough and cold labelling standard (English, HTML)

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Publisher-reported update

2021-09-09

This labelling standard describes the requirements necessary to receive marketing authorization (Drug identification number (DIN)) for oral expectorant nonprescription product containing guaifenesin as a single ingredient for use in adults and children 12 years of age and older to relieve symptoms of common cold.

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