Guidance document: Non-prescription Oral Stool Softener Laxatives Labelling Standard (English, HTML)

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Publisher-reported update

2021-09-13

This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for oral stool softener laxative non-prescription products containing docusate sodium or docusate calcium as a single ingredient for use in adults and children 6 years of age and older to relieve occasional constipation.

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