A breathing problem such as emphysema or chronic bronchitis Trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives
Avoid alcoholic drinks Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery Excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive ingredients D&C yellow no. 10, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch
FIGURE 63–1 Typical FDA-required labeling for an over-the-counter antihistamine. The label must contain, in the following order: active ingredient(s), including the amount in each dosage unit; purpose of product (pharmacologic action); use(s) for product (indication); specific warnings, including when the product should not be used and pregnancy information; when the patient should seek care of a health care provider; side effects and substances or activities to avoid; dosage instructions (when, how, and how often to take medication); and inactive ingredients. Additional requirements include, but are not limited to, the following: type size must be large enough to be easily read, >6-point font type for information in drug facts section; bullets must be solid square or circle 5-point type; and directions in table format for dosage instructions when presented for three or more age groups or populations. Image from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ ucm143551.htm
TABLE 63–3 Hidden ingredients in over-the-counter (OTC) products.
acetaminophen by adults or children can cause serious, and often fatal, hepatotoxicity (see Chapter 4). Antihistamines may cause sedation or drowsiness, especially when taken concurrently with sedative-hypnotics, tranquilizers, alcohol, or other central nervous system depressants.
Finally, use of OTC cough and cold preparations in the pediatric population has been under scrutiny by the FDA based on a lack of efficacy data in children less than 12 years of age and reports of serious toxicity in children. Following a thorough review, the FDA recommends that OTC cough and cold agents (eg, products containing antitussives, expectorants, decongestants, and antihistamines) not be used in infants and children younger than 2 years old due to serious and potentially life-threatening adverse events associated with accidental overdose including arrhythmias, hallucinations, and encephalopathy. Drug information sources for OTC products include the Handbook of Nonprescription Drugs, the most comprehensive resource for OTC medications. It evaluates ingredients contained in major OTC drug classes and lists the ingredients included in many OTC products. Facts and Comparisons eAnswers is an online reference that is updated monthly; it provides detailed OTC product information and patient counseling instructions. Any health care provider who seeks more specific information regarding OTC products may find useful the references listed below.
US Food and Drug Administration: Drug applications for over-the-counter drugs.
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143551.
Consumer Healthcare Products Association website: http://www.chpa.org/.
htm.
Handbook of Nonprescription Drugs, 18th ed. American Pharmacists Association,
US National Library of Medicine: DailyMed. https://dailymed.nlm.nih.gov/ 2015.
dailymed/index.cfm.
Facts and Comparisons eAnswers (online). Wolters Kluwer Health, 2017.