OTC Medicines

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Learn about rules and regulations for structured product labeling of OTC medicines.

Acetaminophen is a safe OTC analgesic that's widely used by adults and children when following recommended dosage guidelines. Lawmakers should oppose restrictions to access for either age group, as drug regulatory entities already actively monitor research and update consumer protections.

Lawmakers should refrain from imposing unnecessary access barriers to diphenhydramine, as leading manufacturers continuously assess and implement efforts to curb teen abuse without limiting adult availability.

Manufacturers have developed an anti-smurfing educational program for the retail setting that is voluntary and offered to retailers at no cost. The intent is to educate potential illegal purchasers about related criminal penalties and how the real-time, stop-sale system works.

Given that prescription medications filled at pharmacies are universally exempt from sales tax, over-the-counter drugs merit the same tax-free status.

Explore consultants who can assist with communications, regulatory policy, strategy, operations, compliance, product development, and more.

This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).

CHPA supports a review of existing rules and coordination efforts to identify opportunities that could mitigate shortage risks during times of peak need.

Under a voluntary program which began in November 2007, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines.

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