This document discusses over-the-counter (OTC) medications, including common conditions they treat like pain, fever, coughs and colds; popular OTC drugs like acetaminophen, ibuprofen, and cough syrups; and FDA regulations for OTC drugs. It covers OTC drug considerations regarding dosages, expiration dates, and inactive ingredients. Specific drug classes are explained, like analgesics, antihistamines, decongestants, antacids, and others. Geriatric and pediatric OTC use is also addressed.

1. 1
Over-the-
Counter
(OTC)
Medications
Chapter 27

2. 2
Over-the-Counter (OTC) Medications
1. Describe the most common conditions treated with over-the-
counter (OTC) products.
2. Recognize OTC drugs used to treat the conditions discussed in
this chapter.
3. Describe the U.S. Food and Drug Administration’s regulations
concerning the manufacture of OTC products.
4. Write the generic and trade names for the OTC drugs
discussed in this chapter.
5. Recognize common dosage forms and safety considerations for
the OTC products discussed in this chapter.
Lesson 27.1

3. Introduction
– Over-the-counter (OTC) medications: No prescriptions
necessary
– Common staples in home medicine cabinet
– Acetaminophen (Tylenol), cough syrup, and ibuprofen
(Motrin)
– OTC drugs: 50% medication purchased
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4. Introduction (Cont.)
– Consumers must learn about appropriate dosages and
proper use of these medications
– Pharmacists need to know what OTC medications are being
taken
– Patients need to know what to avoid
– Buying drugs OTC results in substantial savings
– Consumers use OTC products:
– To be involved in their own treatment
– Because they are more readily available
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5. Over-the-Counter Drug
Considerations
– Wide variety of drugs
– Identify the cause of the problem
– Misuse of drugs contributes to hospital stays
– Expiration dates need to be checked
– Tamper-proof packaging needs to be checked
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6. Over-the-Counter Drug
Considerations (Cont.)
– Dosages for children under 2 years not recommended
– Many OTC medications have identical ingredients
– Manufacturers swap “like ingredients” without notifying
the customer
– The label shows the change
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7. Food and Drug
Administration Regulations
– Follow new drug application (NDA) process before
approval; drugs deemed “generally recognized as safe and
effective (GRASE)” exempt from NDA regulation
– Require OTC monographs
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8. How a Prescription Drug
Becomes an Over-The-Counter
Drug
– “Rx to OTC switch” takes place through one of two
processes:
– OTC drug review process or
– Additional information along with original NDA
– Agent meets criteria: Approved as an OTC drug
– Some legend drugs become OTC: Strength is lowered
– Legend ibuprofen strength (400, 600, or 800 mg)
– OTC ibuprofen strength (200 mg)
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9. Common Conditions Treated
with OTC Drugs
– For common types of OTC products, symptoms treated, and
routes of administration, see common listing
– Tylenol and Motrin are the most common ingredients in OTC
products.
– As new medications enter the market as OTC drugs,
consumers can choose new routes of administration
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10. OTC Agents: Patient
Information
– Analgesics (pain reliever) and antipyretics (anti-fever or
fever reducer)
– Aspirin: Antiinflammatory agent
– Decreases platelets
– Prophylaxis to decrease risk of blood clotting in heart disease
and stroke
– Associated with Reye’s syndrome
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11. Antiinflammatories
– Nonsteroidal antiinflammatory drugs (NSAIDs) treat
inflammation
– NSAIDs inhibit prostaglandins, which are responsible for protecting
the mucous lining of the stomach and intestines
– They reduce pain and are used as antipyretic and analgesic
– May cause drowsiness, upset stomach; take with food or milk
– Most OTC NSAIDs treat inflammation by inhibiting
cyclooxygenase (both COX-1 and COX-2) enzymes.
– COX-1 enzymes protect the lining of the stomach and intestine,
which is why using an NSAID can cause an upset stomach, or, with
long-term use, even ulcers.
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12. OTC Allergy Treatments
– For relief of common cold: Decongestants and
antihistamines
– Decongestants dry out membranes, open airways, cause
vasoconstriction, and reduce congestion
– Antihistamines: Used with allergic symptoms; action blocks
histamine (H1-receptors) that causes allergic reaction
– Combinations: Products that balance the effects can be
useful.
– Should only be used when a patient has symptoms that need to
be relieved by multiple agents.
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13. Cough and Cold Treatments
– Decongestants are indicated for stuffiness and congestion
of nasal passages and sinuses
– They act to open passages and allow release of mucus
– Used for chest congestion: Permit coughing up of phlegm
– Are available in both OTC and prescription preparations
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14. Cough Medications
– Largest OTC section: Cold and flu
– For congested coughs: Expectorants
– For dry non–phlegm-producing coughs: Cough
suppressants
– Dextromethorphan (DXM) is a common OTC cough suppressant
available in liquid and tablet forms.
– Do not use if suffering from asthma, glaucoma,
emphysema, heart problems, or an enlarged prostate
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15. OTC Products for Insomnia
– Diphenhydramine or magnesium salicylate used to treat insomnia
– Diphenhydramine: The most commonly prescribed agent ordered in
hospitals for sleep
– Magnesium salicylate: Analgesic that is available with diphenhydramine in
combination products (Doans PM).
– May cause drowsiness
– Avoid alcoholic beverages
– Do not use if suffering from asthma, glaucoma, emphysema, or an
enlarged prostate
– For chronic insomnia, consult a physician
– These may be habit forming
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16. Gastroesophageal Reflux
Disease and Indigestion
– Many gastrointestinal-related conditions are treated with
OTC products.
– GERD: Gastroesophageal reflux disease
– Common upset stomach remedies (constipation and diarrhea)
– Histamine-2 (H2) antagonists decrease acid secretions
(heartburn)
– Proton pump inhibitors: Relieve acid secretions
– Antacids used to balance pH level in stomach; for short-term
heartburn relief
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17. Intestinal Remedies
– Intestinal discomfort: Constipation, diarrhea, and gas
(flatulence)
– Intestinal products contain oil or saline solution
– For diarrhea: Anticholinergic agent, and bulk-forming fiber
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18. Geriatric and Pediatric
Considerations
– More OTC drugs available in different dosage forms,
strengths, and combinations than legend drugs
– Many senior citizens buy their medications OTC due to a
lack of insurance benefits and may choose the wrong
medication
– Infants and children run a risk of being given an
inappropriate medication, a wrong dose, or the wrong drug
product for their age
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19. Restricted OTC Products
– Several countries that have a third class of drugs that are
referred to as
behind-the-counter (BTC) drugs
– There are certain drugs that are kept behind the counter
and require a log here in the United States:
– Products containing pseudoephedrine
– Only certain amounts can be purchased per day, per month
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