Over-the-counter Drug in United States

Over-the-counter Drug

The term “over-the-counter” redirects here. Over-the-counter trading is a means of trading securities (finance).

Over-the-counter (OTC) pharmaceuticals are medicines that are offered directly to a consumer without the need for a prescription from a healthcare professional, as opposed to prescription drugs, which can only be supplied to consumers who have a valid prescription.

OTC medications are chosen by a regulatory agency in many countries to ensure that they contain components that are safe and effective when taken without the supervision of a physician. OTC medications are often regulated by their active pharmaceutical ingredient (API) rather than their end product. Governments provide manufacturers the ability to create chemicals, or combinations of ingredients, into proprietary mixes by regulating APIs rather than specific medication formulations.

Over-the-counter (OTC) medications are those that can be acquired without a medical prescription. Prescription medications, on the other hand, require a prescription from a doctor or other health care practitioner and should only be taken by the prescribed individual.

Some pharmaceuticals are legally classed as over-the-counter (no prescription necessary), but can only be supplied by a pharmacist after an assessment of the patient’s needs or the provision of patient education. Regulations governing where medications may be marketed, who is authorized to dispense them, and whether a prescription is required vary greatly from country to country.

The Food and Drug Administration regulates the manufacture and sale of OTC substances in the United States. Before entering interstate commerce, the FDA requires all “new medications” to acquire a New Drug Application (NDA), however the statute exempts any drugs that are generally recognized as safe and effective (GRAS/E).

To deal with the large number of OTC pharmaceuticals that were already on the market prior to the need that all drugs get an NDA, the FDA established the OTC monograph system to assess classes of drugs and categorize them as GRAS/E after expert panel evaluation.

Certain kinds of OTC medications would not be required to acquire an NDA and could remain on the market if they followed the monograph requirements for dosages, labelling, and warnings finalized in the Code of Federal Regulations.

Sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing coal tar, and other topical products with a therapeutic effect are examples of OTC substances approved in the United States.

In contrast to prescription drug advertising, which is regulated by the FDA, OTC product advertising is regulated by the Federal Trade Commission.

The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) incorporates improvements that modernize the way certain OTC medications are regulated in the United States. Many OTC monographs need to be revised, but doing so necessitates the lengthy and time-consuming notice-and-comment rulemaking procedure.

The CARES Act includes provisions for OTC monograph reform that replace the regulatory process with an administrative order mechanism.

OTC (Over-the-Counter) Medications

There are over 80 different types of over-the-counter (OTC) pharmaceuticals available in the United States, ranging from acne remedies to weight loss solutions.

OTC pharmaceuticals are medications that are safe and effective for use by the general public without the need for medical attention. Pain medications such as acetaminophen (Tylenol) and ibuprofen (Advil, Motrin), cough suppressants such as dextromethorphan (Robitussin), and antihistamines such as loratadine are popular examples (Claritin 24H). These medications are commonly seen on pharmacy shelves, grocery store shelves, and even petrol station shelves. OTC medications cure a wide range of illness-related symptoms such as pain, coughs and colds, diarrhoea, heartburn, constipation, acne, and others.

What is a Rx-to-OTC switch?

Many OTC pharmaceuticals have undergone a prescription-to-over-the-counter changeover, often known as a “Rx-to-OTC switch,” which means they were previously exclusively available with a prescription but are now available as a non-prescription product.

Proton-pump inhibitors such as esomeprazole (Nexium 24HR) and stomach acid blockers such as famotidine (Pepcid AC), both used to treat heartburn, are examples of Rx-to-OTC products. The emergency contraceptive pill, known as Plan B One Step, is now available without a prescription and may be purchased on the shelves of many pharmacies in the United States.

Image via he Market for Rx-to-OTC Switches, 8th Edition

Are over-the-counter (OTC) medications safe to take?

Even if they do not require a prescription, over-the-counter drugs can pose a risk. Excessive doses have the potential for adverse effects, medication interactions, and injury. Consumers should carefully study the “Drug Facts” label available on all OTC products.

If a patient has any questions about OTC medicine use, they should see their doctor, pharmacist, or other health care practitioner. Pregnant women should consult their doctor before taking any drug, vitamin, or herbal supplement, even if it is available over the counter.

How much cold medicine can you safely take?

Reading the Medicine Facts label on your OTC drug product will help you answer that question, as well as many others. FDA regulations ensure that over-the-counter medications are safe and that the labels are simple to read.

All over-the-counter medications must meet FDA quality, efficacy, and safety guidelines. While these items are easier to access and use than prescription drugs, it is critical to realise that they are medicines with hazards. Before taking any medication, weigh the benefits and hazards to make the best decision for you. Examine the merchandise and ask yourself the following questions:

What is the aim of this medication?
Should I utilize the item?
Is it possible that it will interact with other drugs or foods?
What are the possible consequences?
When should I discontinue the medication and consult a doctor?
How much medication should I take?
How should I take it, how frequently, and for how long?

There are numerous OTC medications on the market:

OTC products come in a variety of forms. Pain relievers and fever reducers; antiperspirants; cough and cold medicines; fluoride toothpastes; emergency contraception; weight loss medicine; heartburn medicines; acne remedies; hair re-growth solutions; and sunscreens are just a few examples. The majority of cough and cold medications are over-the-counter.

Importance of the label:

The Drug Facts label contains all of the information required for the appropriate and safe use of the drug product. “It is vitally important to read the complete Drug Facts label and to not throw it away after you get home. “Information about safe and proper use of the medicine should be available at all times,” Leonard-Segal said. “This will ensure that you and your family members get the most benefit from the OTC drug with the least amount of risk.”

Image via Katie McCallum

The Drug Facts label, which is modelled after the Nutrition Facts food label, employs straightforward language and an easy-to-read format to help people compare and pick OTC medicines and follow dosing instructions.

The following information must be in the following order:

The active constituents in the product, as well as the amount in each dosage unit.
The product’s goal.
The product’s uses (indications).
Specific cautions, such as when the product should not be used under any circumstances and when it is necessary to check with a doctor or pharmacist. This section includes discusses potential adverse effects as well as drugs or activities to avoid.
Dosage instructions—when, how, and how often to take the product.
The inactive ingredients of the product, vital information to help consumers avoid ingredients that may trigger an adverse response.

OTC Guidelines:

OTC medications are those that the FDA has determined are safe to use without the involvement of a healthcare physician. This is not to say that the drugs are without risk or that they are appropriate for all groups.

The concept of an OTC drug is frequently ill-defined and contentious, with advocates arguing that some pharmaceuticals should be marketed without a prescription while others should be removed from pharmacy shelves because they are harmful for OTC use.

This is because of how OTC medications are controlled in the United States. If a new drug with a novel chemical or mechanism of action is introduced, the FDA will require the producer to file a New Drug Application (NDA) before it may be sold interstate.

If, on the other hand, the medicine is simply a new brand of a regularly used drug or one made with commonly used ingredients, it may be free from NDA regulation and allowed to access the market under the “generally regarded as safe and effective” (GRAS/E) classification.

Other pharmaceuticals are “grandfathered” in under terms of the Federal Food, Drug, and Cosmetic Act, even though the FDA does not formally acknowledge or approve their usage. Coal tar, which is used to treat psoriasis, is one such example.

Headaches, Pains and Aches:

OTC pain relievers can assist with headaches, arthritis pain, sprains, and other mild joint and muscle issues.

Acetaminophen– For pain relief, try this medication first. DO NOT EXCEED 3 g (3,000 mg) in one day. A lot of it can be bad for your liver. Keep in mind that 3 grams equals around 6 extra-strength pills or 9 normal pills.
Nonsteroidal anti-inflammatory medications (NSAIDs)– Some NSAIDs, such as ibuprofen and naproxen, can be purchased without a prescription.

Both of these medications can have major negative effects if taken in large dosages or for an extended period of time. Inform your provider if you take these medications several times each week. You may need to be examined for side effects.

Image via Michelle Llamas, BCPA

Fever:

In both children and adults, acetaminophen (Tylenol) and ibuprofen

(Advil, Motrin) can help lower fever.

Every 4 to 6 hours, take an acetaminophen tablet.
Ibuprofen should be taken every 6–8 hours. Ibuprofen should not be used in children under the age of six months.
Before administering these medications, know how much you or your child weighs.

Adults respond quite effectively to aspirin for fever relief. DO NOT GIVE ASPIRING TO A CHILD UNLESS YOUR CHILD’S PROVIDER SAYS IT IS OK.

Cold, Sore Throat and Coughing:

Cold drugs can alleviate symptoms and help you feel better, but they do not lessen the duration of a cold. Taking zinc supplements within 24 hours of the onset of a cold may help to minimize the severity and length of the illness.

NOTE: Before giving your child any form of over-the-counter cold medicine, even if it is labelled for children, consult with your provider.

Cough medications:

Guaifenesin– Aids in the breakdown of mucus. If you’re using this medication, stay hydrated.
Menthol throat lozenges — Relieves the “tickle” sensation in the throat (Halls, Robitussin, and Vicks).
Cough syrups containing dextromethorphan — Reduces the desire to cough (Benylin, Delsym, Robitussin DM, Simply Cough, Vicks 44, and store brands).

Image via GSK Consumer Healthcare

Rashes on the Skin and Itching:

Antihistamines used orally- May assist with itching or allergies.
Hydrocortisone cream- For minor rashes (Cortaid, Cortizone 10)

Creams and ointments with antifungal properties — Diaper rashes and yeast rashes may benefit from this treatment (nystatin, miconazole, clotrimazole, and ketoconazole).

Image via JANET FRICKER

Nausea and vomiting medications:

Liquids and pills for stomach distress- These medications may assist with minor nausea and vomiting (Emetrol or Pepto-Bismol).
Fluids for rehydration — It could be used to replace fluids lost due to vomiting (Enfalyte or Pedialyte).
Motion sickness medications include dimenhydrinate (Dramamine) and meclizine (Bonine, Antivert, Postafen, and Sea-Legs).

Image via Maren Preis

Diarrhea medications include:

Antidiarrhea medications such as loperamide (Imodium) — These medications slow the intestine’s function and lessen the amount of bowel movements. Consult your doctor before using them because they can exacerbate diarrhoea caused by infection.
Bismuth-containing medications- Can be used to treat moderate diarrhoea (Kaopectate, Pepto-Bismol).
Fluids for rehydration — Can be used to treat mild to severe diarrhoea (Analytes or Pedialyte).

ALLERGIES:

Allergy symptoms can be effectively treated with antihistamine pills and drinks.
Diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), brompheniramine (Dimetapp), or clemastine are antihistamines that may produce sleepiness (Tavist).
Loratadine (Alavert, Claritin, Dimetapp ND); fexofenadine (Allegra); cetirizine are antihistamines that induce little or no sleepiness (Zyrtec)
Before giving a child sleep medications, consult with your provider because they can interfere with learning. They can also have an impact on adult alertness.

You might also attempt:

Eye drops–

These are used to soothe or moisturize the eyes.

Cromolyn sodium (Nasalcrom), fluticasone (Flonase).

Image via Drugs & Medications

Throat pain relievers:

Sprays to relieve pain: dyclonine (Cepacol); phenol (Chloraseptic).
Acetaminophen (Tylenol), ibuprofen (Advil, Motrin), and naproxen are all pain relievers (Aleve).
Hard candies that cover the throat — Sucking on candies or throat lozenges can be relaxing. Because of the risk of choking in young children, employ caution.

Decongestants:

Decongestants aid in the clearing of a runny nose and the relief of postnasal drip.
Although decongestant nasal sprays work faster, they can have a rebound effect if used for more than 3 to 5 days. If you continue to use these sprays, your symptoms may worsen.
If you have high blood pressure or prostate problems, consult your doctor before using decongestants.
Pseudoephedrine (Contac Non-Drowsy, Sudafed, and store brand decongestants); phenylephrine (Sudafed PE and store brands).
Oxymetazoline (Afrin, Neo-Synephrine Nighttime, Sinex Spray) and phenylephrine are nasal decongestant sprays (Neo-Synephrine, Sinex Capsules).

Image via Katie McCallum

A Thought from Very-well

Because OTC medications are available in the same stores as soap, vitamins, and bandages, many people believe they are intrinsically safe. This is clearly a mistake. Any drug has the potential to cause harm if it is abused. As a general rule, keep in mind that even the most well-known OTC product:

Is there a risk of overuse and overdose?
Other medicines, including alcohol, may interact with this medication.
It may reduce the efficacy of other medications you are taking.
Some people may develop allergies to it.
It is not recommended for youngsters, pregnant women, or anyone who have liver or kidney disorders.

Important pointers for utilising OTC medications:

Always observe the written instructions and precautions. Before starting a new medication, consult with your doctor.
Understand what you’re getting into. Examine the ingredient list and opt for products with fewer substances.
All medications lose effectiveness over time and must be renewed. Before utilising any product, make sure to check the expiration date.
Medicines should be kept in a cold, dry place. Keep any medicines out of children’s reach.