come in child-resistant packaging. Tablets and cap-
sules 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-diag-
nosed condition (such as HEADACHEor seasonal
allergies). - The drug has a low risk for abuse.
Many OTC drugs are lower-dose versions of
approved prescription drugs and thus have exten-
sive 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 medica-
tions should ask the doctor or pharmacist about
possible problems or interactions.
All drugs have potential side effects, adverse
reactions, and interactions. OTC drugs may inter-
act with each other or with prescription drugs the
person is also taking. Unintentional OVERDOSEmay
occur when taking a prescription drug and an OTC
drug or when taking multiple OTC drugs that con-
tain the same ingredients. This is a particular haz-
ard when taking cold and flu products with
ALLERGYrelief 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 med-
ications for osteoarthritis are often NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS(NSAIDS), the same classi-
fication of drug as OTC pain relievers such as
ibuprofen, ketoprofen, and naproxen. It is impor-
tant to read product labels carefully and ask the
pharmacist about any possible interactions with
other medications.
See also ADVERSE DRUG REACTION; ALCOHOL INTER-
ACTIONS WITH MEDICATIONS; GENERIC DRUG; LEGEND
DRUG; ORANGE BOOK, THE; SCHEDULED DRUG; SIDE
EFFECT.over-the-counter (OTC) drug 167