Over-the-counter medicines
What makes a medicine safe enough to sell without a prescription, and the hidden risks of self-medication.
Over-the-counter (OTC) medicines, called «de venta libre» in Colombia, can be bought without a prescription because they treat mild conditions that people can recognise themselves and have a wide safety margin. They are still real medicines, with side effects, interactions and the possibility of overdose, especially when several products share the same active ingredient.
Why some medicines are sold without prescription
Resolución 886 de 2004 of the Ministry of Social Protection lists the criteria. The medicine should have proven efficacy, a wide therapeutic index and a long safe record on the market; treat mild symptoms that people can recognise; have rare and mild side effects; cause no dependence or accumulation; not hide a serious disease; and not be given by injection. INVIMA's specialised committee reviews the evidence for each product.
Common OTC groups
- Pain relievers and fever reducers: paracetamol, ibuprofen, naproxen, aspirin.
- Antacids, alginates and some acid suppressants.
- Laxatives and antidiarrhoeals such as loperamide.
- Antihistamines and cough and cold combinations, many with decongestants.
- Topical antifungals, such as clotrimazole and miconazole.
Hidden risks
Paracetamol is the classic example: too much causes liver damage that can need a transplant or be fatal, and people often exceed the limit by combining several products that contain it, sometimes labelled with abbreviations. Daily heavy drinking raises the risk. NSAIDs and aspirin can cause stomach bleeding and kidney injury; aspirin given to children or teenagers with flu or chickenpox can cause Reye's syndrome. First-generation antihistamines sedate and are more dangerous in older people. Decongestants raise blood pressure.
Children and pregnancy
Children should receive only products labelled for their age, measured with a proper syringe or dosing cup. Cough and cold combination products are not given to very young children. Many medicines are not safe in pregnancy, so OTC products are checked with a health professional first.
The professional's role
Ask every patient about OTC medicines, herbs and supplements, because they are often left out of the history and they can interact with prescribed drugs. Pharmacists are a key safety check at the point of sale.
Test yourself
Think of the answer, then tap the question to see it.
What criteria must a medicine meet to be sold without prescription in Colombia?
Among others: proven efficacy, a wide safety margin, long safe market use, mild self-recognised conditions, low dependence risk, no masking of serious disease, and not injectable.
How do people most often overdose on paracetamol without meaning to?
By taking more than one product that contains it, such as a cold remedy and a pain reliever, or by exceeding label directions.
Why should people with high blood pressure be careful with cold remedies?
Many contain decongestants, which can raise blood pressure.
Which antidote is used in paracetamol overdose?
Acetylcysteine, most effective when started early.
Example drugs
Connections
Educational content on how drugs work; not a prescribing guide and no substitute for a health professional's advice. No doses are given.
Sources: Resolución 886 de 2004 MPS (Normograma INVIMA (Ministerio de la Protección Social, Colombia), 2004); Over-the-Counter Medicines: MedlinePlus (MedlinePlus (U.S. National Library of Medicine), 2026); Acetaminophen: MedlinePlus Drug Information (MedlinePlus (U.S. National Library of Medicine), 2026); Aspirin: MedlinePlus Drug Information (MedlinePlus (U.S. National Library of Medicine), 2026).
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Representative model, for educational purposes only.