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Over The Counter Drugs

Over-the-Counter Drug Labels

When using over-the-counter (OTC) medication, reading the product label is crucial to ensuring the safety of you and your family.

This is especially the case since most of us take OTC medicine without consulting with a doctor first. OTC medicine labels provide us with logical instructions that, if followed, keep us out of harm's way. Regulations enforced by the FDA certify that all OTC product labels must be organized in a systematic fashion. They must:

  • Contain information listed in a specific order
  • Be arranged in a consistent style that appeals to the eye
  • Use clear, concise terminology to get the point across

All nonprescription, OTC medication labels contain the following information:

  • Active ingredients - curative components in product, amount per unit
  • Uses - how the product remedies illness
  • Warnings - contains advice regarding conditions when it may be inappropriate to be medicated (i.e. pregnant, breastfeeding), reasons to consult a doctor, when to cease product usage, storage away from children
  • Inactive ingredients - useless elements (i.e. colors, flavors)* Purpose - category of drug (i.e. antihistamine, antacid, cough suppressant)
  • Directions - information concerning age of users, how to take, amount to be taken, timeline of use
  • Other information - product storage, required ingredients information(i.e. calcium, potassium, sodium)
  • Expiration date - date at which product is no longer usable, effective
  • Lot or batch code - information provided by manufacturer to classify product
  • Name and address of manufacturer, packer, or distributor
  • Net quantity of contents - amount of product contained in each package
  • Course of action in the event of overdose

OTC manufacturers sometimes alter their products or labeling (i.e. new ingredients, dosage, warnings), so be certain to read the label every time you purchase a product. As a result, beware of special notifications on the product's front label reminding the consumer of any changes.

If you still have questions after reading an OTC label, consult a doctor or pharmacist.