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Drug Safety
Over-the-Counter Medicines
Before taking any over-the-counter (OTC) medicines yourself or giving them to a loved one, you must first read the product label. This is extremely important because OTC medicines are available without a prescription from your physician. All package labels provide easy-to-read usage and safety information as required by the FDA. If you have trouble understanding the instructions or information on a label, then you should ask your doctor, pharmacist, or other healthcare professional before taking the medicine.
The information you'll find on the packaging is as follows:
- Active ingredient; amount of active ingredient per unit
- Therapeutic substance in product
- Uses; symptoms or diseases the product will treat or prevent
- Warnings; when not to use the product, conditions that may require advice from a doctor before taking the product, possible interactions or side effects, when to stop taking the product and when to contact a doctor, if you are pregnant or breastfeeding, seek guidance from a health care professional, keep product out of children's reach
- Inactive ingredients; substances such as colors or flavors
- Purpose; examples include antihistamine, antacid, or cough suppressant
- Directions; dose amount for different ages, how to take, how much, how often and how long, and when to contact a doctor if symptoms do not improve
- Other information; how to store the product properly, and required information about certain ingredients (such as the amount of calcium, potassium, or sodium the product contains)
- Expiration date; medicine should be discarded after this date
- Lot or batch code; information for the manufacturer to identify the product
- Name and address of manufacturer, packer, or distributor
- Net quantity of contents; how much medicine is in each package
- What to do if an overdose occurs
The manufacturers of OTC medicines do make changes to their products or labeling, so be sure to check for such changes each time you buy the product. They may add or change ingredients, dosage amounts or product warnings. In most cases, they will alert you to such changes by placing a special "flag" or "banner" on the front of the package.
For additional information on over-the-counter medicines, please visit the following sites:
- Rx List
- U.S. Food & Drug Administration
- Drug Info Zone
- MedlinePlus
- U.S. Department of Health & Human Services
- FDA Drug guide
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