Question: What Must An OTC Drug Label Include?

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..

Which of the following are characteristic of OTC drugs?

Necessary characteristics for OTC drugs include:The product has an acceptable safety margin.The product has low misuse and abuse potential under conditions of widespread availability.A healthcare practitioner is not needed for the safe and effective use of the product.The product has adequate labeling.

What makes a product OTC?

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription.

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 are OTC products with examples?

Popular examples include pain relievers like acetaminophen (Tylenol) and ibuprofen (Advil, Motrin), cough suppressants such as dextromethorphan (Robitussin) and antihistamines like loratadine (Claritin 24H). These drugs are usually located on shelves in pharmacies, grocery stores, and even in gas stations.

How do you reference the FDA?

medications: FDA public health advisory….Citing a Government PublicationTreat a government document as a book, report, or brochure.If a person is named on the title page, use her or him as author.If no person is named, use the government agency, department, or branch as a group author (Ex.More items…•

What are the different classes of OTC drugs?

otc drug monographs with professional labeling include those in the following drug categories:Antacid.Antiflatulent.Topical Antifungal.Antiemetic.Cough and cold.Internal analgesics.Ophthalmic.Anticaries.More items…•

What information does a drug label contain?

All prescription medicine containers include information on the label including the patient’s name, the name of the medicine, dosage and instructions on how often to take the medicine. More detailed printed information about the medication is usually provided by the pharmacy when prescription medicine is dispensed.

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 are the eligible OTC items?

Eligible items include but are not limited to: fiber supplements, first aid supplies, medicines, ointments, sprays with active medical ingredients that alleviate symptoms, topical sunscreen, supportive items for comfort such as knee braces and adult incontinence products, and mouth care such as dental floss and …

What does it mean when you develop a tolerance for medication?

Tolerance is common. It can develop when your body is regularly exposed to a medication. If your body has developed a tolerance to a medication you’re taking, it means the medication at your current dose has stopped working as effectively as it once did.

How do you cite a drug label FDA?

To be clear, the year of publication refers to the latest available revision of the drug package insert, which can be found on the FDA website: Print source: Name of Medicine [package insert]. Place of publication : Publisher; Year of publication/revision.

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.

How do you cite a drug label?

Please use the following format. Drug name [package insert]. Place of publication: Manufacturer’s name; Year of publication.

Do OTC products need FDA approval?

Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review.

How do you cite drugs in APA?

Page Title; Copyright; [Date page last updated; Date of citation]. URL. For Example: [Internet].