Frequently Asked Questions about Labeling for Prescription Medicines

Boxed Warning (sometimes referred to in lay terms as a “black-box warning”)Contains contraindications or warnings about serious adverse reactions2 that may lead to death or serious injuryPlaced prominently at the beginning of the Full Prescribing InformationWords are bolded and surrounded by a single black line (box) 1 Indications and UsageFDA-approved uses that are supported by substantial evidence of effectiveness, with benefits that outweigh risks2 Dosage and AdministrationRecommended dosage (recommended dose and dosing frequency)Dosage rangeRecommended starting dosage and titration scheduleMaximum recommended dosageRoute(s) of administrationPre-medication or concomitant medicinesDosage modifications due to drug interactions with other medicines or foodsRecommended dosage in specific populations (e.g., pediatric patients, patients with renal or hepatic impairment)Preparation instructions (reconstitution of the supplied powder, dilution)Administration instructions3 Dosage Forms and S...