Drug facts label
Drug facts label is an obligatory description for Over the counter – OTC medicines in USA.
Designed similarly to the Nutrition Facts food label, the Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions. The following information must appear in this order:
- The product’s active ingredients, including the amount in each dosage unit.
- The purpose of the product.
- The uses (indications) for the product.
- Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
- Dosage instructions–when, how, and how often to take the product.
- The product’s inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.
See also FDA Information.