FAQ

Questions about your over-the-counter (OTC) medicines? We’re here to help. Read on for answers to some of the most commonly asked questions about OTCs.

Frequently Asked Questions

Over-the-counter medicine is also known as OTC or nonprescription medicine. These terms refer to medicine that you can buy without a prescription.

OTCs can treat a wide variety of symptoms and ailments. Some OTCs provide temporary relief to pain, allergies, and minor cuts. Others treat recurring symptoms and conditions, like migraines or heartburn. Always match your symptoms to the OTC you are taking, and ask your healthcare provider or pharmacist if you have any questions.

OTC dosage directions are instructions that should be followed exactly, unless a healthcare provider specifically tells you otherwise. This means you should never take more of a medicine than the label says, or for a longer period of time than the medicine label says. While OTCs are safe and effective when taken according to the label, no medicine is without risk, including OTCs.

Always read and follow medicine labels to understand dosage strength and unique dosing directions for each OTC. Taking more than directed can lead to an overdose. Avoid taking multiple medicines that contain the same active ingredient, and never take a medicine for a longer period of time or in higher doses than the label recommends.

The label for OTCs is called the Drug Facts label. This is the type of label using rule by the U.S. Food and Drug Administration (FDA) for the back and often the sides of the OTC box or package. It presents important information for the safe and effective use of an OTC in the same format and order for every medicine. Every OTC Drug Facts label on store shelves has been approved by FDA.

Pregnancy is an exciting time and a great chance to take charge of your health. For many women, when you are pregnant or nursing you are more likely to pay more attention than ever to what goes into your body and you know that not all medicines are safe to take while pregnant or breastfeeding.

Back pain and heartburn are two of the most common discomforts that come along with pregnancy, so be sure to discuss the products that can help you safely relieve those symptoms with your healthcare provider or pharmacist. The best thing you can do for your health and the health of your baby is to talk to your healthcare provider before taking any medicine when pregnant, breastfeeding, or when planning to become pregnant.

Your healthcare provider can provide the best information about whether an over-the-counter (OTC) medicine may be right for you, but always keep the following tips in mind:

  • Discuss taking any medicines during your pregnancy with your healthcare provider.
  • Do not take certain pain relievers during the last three months of your pregnancy, since they may cause problems in your unborn child or complications during delivery.
  • When breastfeeding, always ask your healthcare provider before taking any medication.
  • If your healthcare provider recommends you take medication while breastfeeding, time it so that you can take the medicine after nursing or before your baby’s longest nap.

When giving medicine to children, it is important to only use a product that treats your child’s specific symptoms. Do not give a medicine only intended for adults to a child. When possible, dose by your child’s weight following the instructions on the label. Always give the recommended dose and use the correct measuring device. And remember; keep all medicines and vitamins out of your child’s reach and sight. Ask your healthcare provider if you have any questions.

Just like the dosing instructions and additional information on the label, the expiration date on the packaging is there for reason. Once a medicine has reached its expiration date, it may not provide the treatment that you need. To ensure the medicines you take are both safe and effective, keep an eye on the expiration dates and safely dispose of any expired or unwanted medicines.

Follow these simple steps from the U.S. Food and Drug Administration (FDA) to dispose of OTCs in your household trash:

  • 1. Mix medicines (do not crush tablets or capsules) with an unpalatable substance such as kitty litter or used coffee grounds.
  • Place the mixture in a container such as a sealed plastic bag.
  • Throw the container in your household trash.

Dietary supplements are products that may contain vitamins, minerals, botanical or herbal ingredients, amino acids (the building blocks of proteins), and enzymes (complex proteins that speed up biochemical reactions). They are sold in various forms, including tablets, capsules, softgels, gelcaps, or liquids. They are meant to supplement a diet but should not be considered a substitute for food.

Examples of commonly used dietary supplements:

  • Vitamins
  • Minerals
  • Echinacea
  • Omega-3 Fatty Acids
  • Ginger
  • St. John’s Wort
  • Glucosamine
  • Chondroitin Sulphate
  • Fiber
  • Saw Palmetto
  • Acidophilus

Why Consumers Use Dietary Supplements

Vitamins are essential for good health through every stage of life. Our bodies require a broad variety of vitamins and minerals to function properly, yet it can be challenging to get all the nutrients we need from food alone.

Consumers should strive to maintain an overall healthy lifestyle that includes regular exercise, eating a healthy diet, getting enough sleep, and visiting a healthcare provider regularly. Dietary supplements can be used responsibly as a way to fill nutritional gaps and enhance health.

People use dietary supplements for a number of reasons, including:

  • Maintaining their general health
  • Supporting mental and sports-related performance
  • Providing immune system support

Dietary Supplements and Health Claims

It’s important to note that dietary supplements are not medicines. In general, manufacturers of dietary supplements are not allowed to say that their products can diagnose, cure, treat, or, with special exceptions, prevent disease. For instance, a dietary supplement cannot make a claim to “reduce arthritis pain” or “treat heart disease.” However, based on evidence, manufacturers can say that their dietary supplement contributes to health maintenance, well-being, or supports a function of the body.

Where backed by sufficient evidence, some supplements may make claims about the role of an ingredient in preventing certain conditions. For example: “Adequate folate in healthful diets may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.”

Government Oversight of Dietary Supplements

The FDA does not approve dietary supplements for safety before they are marketed. If a dietary supplement contains a new ingredient (one that was not marketed before October 1994), that ingredient will be reviewed for safety by the FDA prior to marketing.

Manufacturers of dietary supplements are responsible for their safety, so must follow a number of standards meant to ensure quality in the manufacturing, packaging, and labeling of their products. Dietary supplement manufacturers must also keep track of adverse events reported in association with their products and report all serious adverse events to the FDA. Advertising of dietary supplements is regulated by the Federal Trade Commission.

Important Tips for Safe Use

Used as directed, dietary supplements have a wide margin of safety but they do contain ingredients that have biological effects on the body. In some situations, this could lead to an adverse event associated with the use of the product.

  • Always follow the instructions on the label when taking dietary supplements and do not take more than the recommended dose.
  • Inform your healthcare provider about any supplements you are taking, especially if you plan to have a surgical procedure.
  • If you think you have suffered a serious harmful effect or illness in association with the use of a dietary supplement, see your healthcare provider immediately.
  • You are also encouraged to report this event to FDA’s MedWatch Hotline at 1-800-FDA-1088.

Can I take dietary supplement products with prescription or OTC medicines?

Yes. However, because dietary supplements have a number of biological effects on the body, they can interact with some OTC medicines or prescription drugs, potentially leading to an adverse event. Prior to taking any dietary supplement, consumers should inform their healthcare provider about ALL of the products they are taking—prescription drugs, OTC medicines, AND dietary supplements.

Is there any scientific research on dietary supplement products?

Yes, but the amount of scientific evidence available to demonstrate the claims of various dietary supplement ingredients can vary. Some dietary supplement ingredients, like calcium and vitamin D, have been studied extensively, so their health benefits are well known and well documented. Other dietary supplement ingredients may have not been studied as much. The makers of dietary supplements must have evidence in their files to show that claims they make are truthful and not misleading. Manufacturers of dietary supplements containing new ingredients (those not sold as a dietary supplement before October 1994) must notify FDA of their intent to market a dietary supplement containing the new ingredient and provide information on the safety of the product.

Where can I buy dietary supplements?

Dietary supplements are available at a wide variety of stores, including supermarkets, health food stores, direct sellers, and convenience stores and are also available for purchase via the Internet. If you choose to purchase a dietary supplement from an Internet site, it is important to be sure that the company is well-known and trusted.

How can I be sure that the dietary supplement I am taking is safe?

Most of the dietary supplements on the market today have an excellent safety record, and their manufacturers comply with all requirements for product ingredients, claims, and labeling. However, FDA does occasionally find dietary supplement products that do not comply with these requirements.

It’s always best to purchase dietary supplements and all other types of health products from a trusted company. Be especially careful when purchasing dietary supplements from the Internet. If a claim sounds too good to be true, it probably is. Avoid purchasing dietary supplements that promise miracle results, or say that they work in a short amount of time (i.e., “fast” or “rapid action”), or claim to be “totally safe.”

Have there been any safety issues with dietary supplements? 

Recently, the FDA has observed a small number of manufacturers attempting to market dietary supplements containing extra ingredients not listed on the product label. This has occurred mostly in products intended for weight loss, body building, and sexual enhancement. Know what you are taking. The FDA maintains a website on health fraud scams. For more information, please visit the FDA’s website.

Are dietary supplements labeled “natural” free of side effects?

Not necessarily. Do not assume that a product labeled as “natural” will be safer than a product that is not.

What is a structure/function claim? 

Structure/function claims describe the role of a nutrient or dietary ingredient in affecting the structure or function of the body in humans. An example of this would be “calcium builds strong bones.” If a dietary supplement label includes a structure/function claim, it must also state that FDA has not evaluated the claim and that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease.”

Homeopathic medicines contain very small amounts of natural substances derived from plants, minerals, and biological substances, and have been used for more than 200 years to relieve different symptoms. Because of their history of safety, these medicines are often used in treating self-diagnosable conditions, such as the common cold, indigestion, muscle soreness, allergies, and insomnia. Over-the-counter (OTC) homeopathic products are available in many forms, including capsules, creams, eye drops, gels, granules, liquids, lozenges, nasal sprays, ointments, pills, tablets, suppositories, and syrups.

What Homeopathic Medicines Are Used For

Many common, minor ailments have been treated effectively with homeopathy medicines, including allergies, coughs, colds, flu-like symptoms, stress, muscle pain, and teething pain.

How Homeopathic Medicines Work

Homeopathic treatments are based on the “principle of similars,” which loosely means “let likes be cured by likes.” Essentially, if a substance causes a symptom in a healthy person, giving the person a very small amount of the same substance can be used as treatment for the symptom. For example, exposure to a high dose of red onion—Allium cepa—produces a runny nose and watery eyes. However, a small dose of Allium cepa can be used to relieve a runny nose and watery eyes often associated with a cold or hay fever.

How Homeopathic Medicines Are Regulated

Homeopathic medicines are regulated as drugs by the U.S. Food and Drug Administration (FDA). Standards for these medicines are set through the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), and the products must contain active ingredients listed in the Homeopathic Pharmacopoeia of the United States (HPUS).

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