Question: What Is Required On An OTC Label?

What is Rx to OTC switch?

Rx-to-OTC switch refers to the transfer of proven prescription drugs (Rx) to nonprescription, OTC status.

Rx-to-OTC switch is a data-driven, scientifically rigorous, and highly regulated process that allows consumers to have OTC access to a growing range of medicines..

What are the three criteria that must be met by an OTC drug?

Thus, an OTC drug must satisfy 3 criteria: (1) it must be safe, (2) it must be effective, and (3) it must be for a condition that the patient can manage without supervision by a licensed health professional.

What information is required to be displayed on the labels of OTC medication quizlet?

What information is required to be displayed on the labels of OTC medication? The labels of OTC medicines include important information about when to take the drug, possible side effects, dosage, and intended uses. Compare and contrast vaccines and antitoxins.

What are the basic rules for using OTC drugs properly?

Top 10 Tips for Safely Using Over-The-Counter MedicinesConsult your doctor or pharmacist before purchasing an OTC product. … Read the label carefully. … Do not take medicines with the same active ingredients. … Only treat the symptoms you have. … Keep a current list of medicines you take. … If you are pregnant or breastfeeding consult with your doctor before taking an OTC medicine.More items…•

What is required on a drug label?

Most pharmacies have the name, address, and phone number of the pharmacy pre-printed on their prescription labels. In addition, federal and state (NC) regulations require that the following information appear on the label.

Do OTC products need FDA approval?

OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. … Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval.

What is drug labeling?

Drug labelling, also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal.

How do you read over the counter labels?

Each medicine should list the same types of information in the same order.Active ingredient. The active ingredient is the chemical compound in the medicine that works to relieve symptoms. … Uses. … Warnings. … Directions. … Other information. … Inactive ingredients. … Questions or comments.

What is label in pharmacy?

The term “label” designates that part of the labeling upon the immediate container [2]. In other words, “labeling” can refer to drug products from a manufacturer, and “label” can apply to drug products dispensed by a pharmacist on a prescription order.