OTC Medicines

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FAQs

FAQs About Reforms to the OTC Monograph System
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Guidelines for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA

Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.

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Preventing Dextromethorphan Abuse

CHPA supports legislation that would prohibit the sale of over-the-counter (OTC) cough medicines containing dextromethorphan to teens under the age of 18.

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FAQs

FAQs About Acetaminophen and Other Oral OTC Pain Relievers and Fever Reducers

Find frequently asked questions about OTC oral pain relievers and fever reducers including acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium.

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In-use Product Stability Testing for OTC Products – Advisory Document

The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, shelf life for the drug product and recommended storage conditions.

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