The labels of OTC medicines include important information about when to take the drug, possible side effects, dosage, and intended uses. Antibiotics kill harmful bacteria or prevent bacteria from reproducing. Most medicines have secondary symptoms called side effects.
What do you need to know about OTC drug labels?
OTC Drug Facts Label | FDA OTC Drug Facts Label Whenever you use an over-the-counter (OTC) medicine, reading the drug product's labeling is important for taking care of yourself and your family. The label tells you what the medicine is supposed to do, who should or shouldn't take it, and how to use it.
What information should be included in a drug label?
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.
When did the OTC label format change?
This regulation required most OTC drug products to comply with the new format and content requirements by May 2002. Manufacturers may continue to use old-format labels until their inventories are exhausted.
What are the symptoms of generic OTC medicines?
Symptoms can include headache, nausea, insomnia, and nervousness. Generic OTC medicines have the same active ingredients as the brand-name OTC medications. Which of the following is the legal method for obtaining prescription medicines?
What are four pieces of information that must be on an OTC medicine label?
The Over-the-Counter Medicine Label: Take a LookActive Ingredient. Therapeutic substance in product; amount of active ingredient per unit.Uses. Symptoms or diseases the product will treat or prevent.Warnings. ... Inactive Ingredients. ... Purpose. ... Directions. ... Other Information.
What information is required to be placed on the label of the medication?
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 requirements for packaging and labeling OTC drugs?
These requirements include:The proprietary name of the drug.The established name of the drug, if one exists.An identifying lot or control number.The name of the manufacturer, packer, or distributor of the drug.The National Drug Code (NDC) number.Adequate Directions for Use.Statement of Ingredients.More items...•
What is not included on a OTC medicine label?
tolerance. Which is NOT included on an OTC medicine label? intentionally taking medications for non-medical reasons.
What information is required on a label of a prepackaged drugs?
SPECIFIC INFORMATION THAT CAN BE FOUND on prepackage medication labels is as follows: nonproprie tary name, trade name, pharmaceutical and pharma cological classifications, concentration per dosage unit, routes of administration, expiration date, warnings, storage requirements, and control number.
What is the most important information you should know about the drug in the label and why?
Warnings. This is one of the most important parts of the drug label, and it's usually the largest. It gives you safety details about the medicine. You'll find four things here: who shouldn't take the drug, when you should stop using it, when to call your doctor, and side effects you might have.
What are the requirements for OTC drugs?
FDA requirements for OTC drugs (OTC monograph product)- Establishment Registration – Manufacturing facilities involved in manufacturing, packing, and processing the drug must be registered with the FDA. NDC drug listing – Drug listing is a mandatory requirement for all the drug products marketed in the USA.
Do OTC drugs require FDA approval?
OTC drugs can be bought and used safely without the need for a prescription. All OTC drug products have to meet FDA quality, effectiveness, and safety standards. While easier to obtain and use than prescription drugs, it is important to understand that these products are medicines and not without risks.
What are the parts of a drug label?
PARTS OF A DRUG LABELTRADE NAME. The trade name (also known as brand or proprietary name) is usually capitalized and written in bold print. ... GENERIC NAME. The generic name is the official name of the drug. ... DOSAGE STRENGTH. ... FORM. ... ROUTE. ... AMOUNT. ... DIRECTIONS.
What is OTC in pharmacy?
Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional.
Which of the following information is found on stock medication labels?
Stock bottle labels require the following: The brand name, the generic name, the medication's strength, the legend statement, storage requirements, the package quantity, the medications doasge form, the manufacturer's name, the controllled substance mark, the lot number, the expiration date, the ndc number.
Why is it important to read the label on an OTC medicine?
Whenever you use an over-the-counter (OTC) medicine, reading the drug product's labeling is important for taking care of yourself and your family. The label tells you what the medicine is supposed to do , who should or shouldn't take it, and how to use it. The labeling of OTC medicines has always contained usage and safety information for consumers.
How many OTC labels are there?
Manufacturers may continue to use old-format labels until their inventories are exhausted. The OTC labeling rule applies to more than 100,000 OTC drug products. Before simplifying the OTC label, the FDA conducted extensive research on how consumers use OTC drug product labels.
What is the drug facts label?
Patterned after 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.
What is the problem with OTC labels?
One major problem has been the readability of the labels, especially for older Americans, who purchase almost 30 percent of the OTC drugs sold in the United States. The FDA also found that consumers thought words like "indications," "precautions," and "contraindications" were confusing and not easily understood.
When did the OTC drug facts label come out?
With the introduction of the "Drug Facts" label, the information is more uniform and easier to read and understand. In the Federal Register of March 1999 , the Food and Drug Administration published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002.
What is the purpose of the inactive ingredients label?
The product's inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction. Along with the standardized format, the label uses plain-speaking terms to describe the facts about each OTC drug. For example, "uses" replaces "indications," while other technical words like "precautions" ...
What are the symptoms of withdrawal from a medication?
Symptoms can include headache, nausea, insomnia, and nervousness. Generic OTC medicines have the same active ingredients as the brand-name OTC medications. T.
Is it bad to take someone else's medication?
Explain why it is a bad idea to take a friend's prescription medication. Taking someone else's medications is against the law. In addition, prescription medicines were given to your friend by a doctor who clearly understood the health issues at hand. Those same medicines can cause harm to other individuals.
What is the OTC label?
Each OTC medicine has a drug facts label printed on the package . This label gives you important information. It tells you what the medicine does, how to take it safely, and who shouldn’t take it. You always should read the label before buying or using the medicine.
What is the first item on a medicine label?
There are several sections of information on the label. 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. It is the first item listed on the label.
What is an OTC drug?
How to Read an OTC Drug Facts Label. Over-the-counter (OTC) medicines are drugs you can buy without a doctor’s prescription. Examples include pain relievers, allergy medicines, and cough and cold medicines. Vitamins and supplements also are sold over the counter.
What is an inactive ingredient?
An inactive ingredient is anything in the medicine that isn’t meant to treat a symptom. This can include preservatives, binding agents, and food coloring. This section is important for people who have allergies to food coloring or other chemicals. Questions or comments.
What is the safety information on a med?
This safety information tells you the possible side effects of the medicine. It lists certain medicines, foods, or situations to avoid while taking this medicine. For instance, you may need to avoid drinking alcohol or driving a car. Warnings also tell you if you should talk to a doctor before you take the medicine.
What measuring device do you use to measure a liquid medicine?
For liquid medicines, make sure you use the correct measuring device, such as a measuring spoon, syringe, or cup. Other information. Other important information, such as how to store the medicine, is listed here. Inactive ingredients.
Can you take OTC medicine if you are pregnant?
If you are pregnant or have a health condition, they can tell you if an OTC medicine is safe to take. Stop taking an OTC medicine if you have a reaction.