Definition of Over-The-Counter (OTC) drug

over the counter otc drugOver-The-Counter (OTC) drug – In the United States, a drug that is available for purchase without a prescription and that does not require a pharmacist to dispense.

However, US laws do require OTC product labels to list the product’s active ingredients, main inactive ingredients, strength, recommended dosage, significant side effects (such as drowsiness), and any health conditions a person might have in which the person should not take the drug.

Furthermore these drugs must meet drug purity, consistency, and safety standards. OTC drugs are available in a wide variety of retail locations. Most OTC products come in child-resistant packaging. Tablets and capsules may come in bulk or single-dose packaging.

The US Food and Drug Administration (FDA) oversees the approval of new OTC drugs, which must meet the general criteria that:

  • The drug’s benefits outweigh its risks.
  • A person can take the drug to treat a self-diagnosed condition (such as headache or seasonal allergies).
  • The drug has a low risk for abuse.

Many OTC drugs are lower-dose versions of approved prescription drugs and thus have extensive clinical history that demonstrates their relative effectiveness and safety. Though OTC drugs are generally safe to take without a doctor’s oversight of either the drug’s use or the condition the person is taking the drug to treat, people who regularly take prescribed or doctor-recommended medications should ask the doctor or pharmacist about possible problems or interactions.

All drugs have potential side effects, adverse reactions, and interactions. OTC drugs may interact with each other or with prescription drugs the person is also taking. Unintentional overdose may occur when taking a prescription drug and an OTC drug or when taking multiple OTC drugs that contain the same ingredients. This is a particular hazard when taking cold and flu products with allergy relief products, when taking pain relief products with cold and flu products, and when taking prescription drugs to treat osteoarthritis with pain relievers or cold and flu products.

Many cold and flu products contain an antihistamine and an ingredient to relieve pain and fever, such as acetaminophen or ibuprofen. Prescription medications for osteoarthritis are often nonsteroidal anti-inflammatory drugs (nsaids), the same classification of drug as OTC pain relievers such as ibuprofen, ketoprofen, and naproxen. It is important to read product labels carefully and ask the pharmacist about any possible interactions with other medications.


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