By: Elise M. Rizzi

We’ve all been there – you wake up with a pounding headache, stuffy nose, body aches, chills, the whole nine yards. You head to the store to see what meds you might be able to find to help. The pharmacy aisle (Figure 1) is so overwhelming, with bright labels and long words, all promising something different – where do you even start?

The slew of medications that can be purchased from your local pharmacy might have you in a tizzy on top of already feeling under the weather. So, let’s go over some of the basics now so that you can make informed decisions when you’re down and out with the season’s latest viral hit.

What are OTC medications and how are they regulated?

Over-the-counter (OTC) medications are drugs that you can buy from a pharmacy or other retailer without a prescription from a healthcare provider or pharmacist. In the US, the Food and Drug Administration (FDA) regulates which medications are available OTC. Decisions to allow a drug to be purchased OTC are made based on the safety profile and efficacy of the drug.² The FDA determines whether or not the benefits of having a drug available without a prescription outweigh the potential risks.  One benefit is a decrease in barriers to care, allowing medications to be obtained without having to see a medical provider. Barriers disproportionately impact minority and lower socioeconomic groups, and the availability of medications OTC can improve access to care. However, any risks associated with OTC meds that are not appropriately considered also put individuals in these groups at higher risk which must be considered when deciding if a medication should be available OTC.

If they’re OTC, they must be harmless, right?

False. The reality is that all substances (even water!) have a dose at which they are toxic. OTC medications, like all medications, have potential risks and side effects. Holding an OTC classification means that these risks and side effects are relatively low when taken as directed. To identify the directions for dosage, contraindications (circumstances in which not to take), and guidance (when you should see a doctor) look at the label on the back, inside label, or information packet located on or in the packaging for the medication labeled Drug Facts as seen in Figure 2. This label will detail the medication’s active ingredients, which are the substances in the product that provide the advertised therapeutic effect (what makes you feel better!), its purpose (often a pharmacologic category), and the amount of this ingredient per dosage. The uses section will detail symptoms or diseases the product may be able to treat or prevent, followed by the warnings section which details the most common side effects and contraindications. The Drug Facts label also includes directions wherein different dosages based on age, condition, weight, or other factors are listed.³

Why are some OTC meds only available “behind the counter” or have other barriers to access?

Medications that are safe and effective at recommended uses, but also have the potential for abuse at higher doses or when modified, are regulated more heavily to maintain consumer safety. For example, some medications are only available in blister packs (plastic/foil cases that individually package pills). Blister packs have a limited number of pills per pack and require each pill to be individually opened, which impose a deterrent/physical barrier to overuse or abuse when compared to an easy-to-open bottle filled with dozens of pills. Some medications, such as decongestants containing pseudoephedrine (Sudafed), are only available “behind the counter.” “Behind the counter” means you must go to the pharmacist and ask for the medication rather than picking it up off the shelf by yourself. You may also need to show your ID to the pharmacist to demonstrate that you are of appropriate age. These regulations limit the quantities of these medications purchased by a single individual or a minor. Especially strict regulations/limitations are important as the active ingredients in these drugs can be used to manufacture drugs with addictive and/or psychotropic properties.⁴

Can I utilize my health insurance to pay for OTC meds?

Sometimes! Your healthcare provider/prescriber can prescribe a medication that is available over the counter, though oftentimes these medications are not covered by prescription medication insurance plans. However, if you have a flexible spending account (FSA) or health savings account (HSA) as a part of your healthcare plan, many OTC drugs are eligible for purchases made with FSA/HSA cards or for reimbursement with receipt.⁵ Insurance plans vary, and you should verify with your individual insurance plan if a given drug is covered or not.

Is a combination cold/flu medication a good choice?

Buyer beware – combination medications have higher likelihood of accidental overdose or medication interactions. These combination cold/flu medications can be useful to treat multiple symptoms of an illness, but it is important to know what active ingredients are present in the medication to prevent misuse. For example, you might not think that your generic “cold tablet” would have an antihistamine (anti-allergy) ingredient in it, but they often do. So if you didn’t check the active ingredients you may have also taken your daily allergy pill – inadvertently increasing your dose of a single active ingredient or drug class.⁶

Are brand name medications better than generic/store brand?

No, generic and brand name medications have the same active ingredients, meaning they are the same medication and share the same efficacy and safety profile. However, brand name and generic medications can have different inactive ingredients, such as colors, flavorings, and other additives like binders that keep tablets together. In the case of an allergy or intolerance, these inactive ingredients (also shown on the Drug Facts label in Figure 2) may be relevant, but they do not otherwise change the effectiveness of the medication.⁷

TL;DR

• Over-the-counter (OTC) drugs are generally safe, but still have possible risks/side effects
• Some OTC medications are more heavily regulated to decrease potential overuse/abuse
• Know the active ingredients in the medications you are taking
• Generic and brand name drugs have the same active ingredients

---

Reference

1. Health, C. Decoding the Drugstore Aisle. Chicago Health. https://chicagohealthonline.com/decoding-the-drugstore-aisle/ (accessed 2025-01-24).
2. Research, C. for D. E. and. Over-the-Counter Medicines: What’s Right for You? FDA 2024.
3. Research, C. for D. E. and. The Over-the-Counter Drug Facts Label. FDA. https://www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-drug-facts-label (accessed 2025-01-24).
4. Research, C. for D. E. and. Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. FDA 2024.
5. List: Tylenol and 73 Other Popular OTC Meds That Are FSA/HSA-Eligible – GoodRx. https://www.goodrx.com/insurance/fsa-hsa/list-of-otc-fsa-eligible-meds (accessed 2025-01-24).
6. Combination Cold Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing – WebMD. https://www.webmd.com/drugs/2/drug-55394/combination-cold-oral/details (accessed 2025-01-24).
7. Research, C. for D. E. and. Generic Drugs: Questions & Answers. FDA 2024.