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How to make sense of the information that accompanies over-the-counter medicines

How to make sense of the information that accompanies over-the-counter medicines

Whether you’re taking a specific over-the-counter (OTC) medication for the first time, or comparing brands on the shelf, you’ll be a more informed consumer if you develop an understanding of pharmaceutical labelling (MCC, 2010) and the package insert, which is the information leaflet that accompanies all medicines. Both can help you to properly choose and use the products.

Look for the following information on the medication’s packaging or in the accompanying leaflet, to get a picture of what’s inside, advises Graham Anderson of Profmed (2012):

1. Presentation

These are the physical characteristics of the medication, including colour, shape, and markings, to help you determine that you’re taking the right thing.

2. Volume

Volume appears as a number of tablets, a volume in mililitres (ml) or a weight in grams (g). This is the physical quantity of the product, which will help you to ensure that there’s enough to last the length of time you’re supposed to take it. You can also compare similar products in terms of cost.

3. Dose

The amount of medicine to be taken is usually listed for adults and children (with age categories): how much to take, how to take it, and how often and for how long it should be taken (USFDA, 2016). If you’re in doubt about the correct dosage for an ailment, chat to your pharmacist or other healthcare practitioner.

4. Active ingredients

This is the pharmaceutical name of the therapeutic substance in the product – the one that’s responsible for the action of the medicine (USFDA, 2016). You’ll also see the amount of active ingredient per recommended dosage unit, either in ml or microlitres (μI). Why would you need to know this? When comparing brands. In case you have a hypersensitivity (allergy). In case there is a drug interaction with a medicine or supplement you are already taking.

5. Schedule

If the medication is a scheduled drug, this information must appear on the label, says Anderson (2012). According to Essentials (2016), schedules go from S0 to S6, increasing in regulatory control as the number gets larger.

While S0 (aspirin, vitamins and some topical creams) can be sold in supermarkets, health shops, service stations, pharmacies, and other retailers, S1 upwards must be sold in a pharmacy. S1 and S2 (cold and flu remedies, antihistamines and anti-inflammatories) can be bought without a prescription, as can some S3 medications for certain indications and for a limited duration.

In South Africa, a prescription is needed for anything higher than S3.

6. Expiry date

This is important if you’re going to be keeping or storing the drug. All medications have expiry dates that must be taken seriously, because their strength may change over time. Alternatively, there may be a breakdown in some of the ingredients, with potentially dangerous byproducts.

7. Storage instructions

Most medicines must be kept in a cool, dry place below 25 degrees. If a medication must go into the fridge, it will say so. Please pay special attention to these instructions, as ignoring them can destroy the medicine.

Other details

– Approved uses
for the medicine; in other words, the symptoms or diseases the product will help to treat or prevent
– The manufacturer of the product, the product’s registration number and the contact details of the holder of the registration certificate
– Precautions and measures to ensure safety in normal usage and in situations of overdose

Helpful tips

Always remember to look out for special precautions in cases where:

– the patient is pregnant or breastfeeding,
– the patient’s age is important (very young or very old),
– there’s a pre-existing condition (hypertension, heart disease, etc.),
– there are restrictions relating to alcohol use, or
– the medication can cause drowsiness or impaired concentration.

Be aware, also, that the manufacturers of OTC medicines sometimes make changes to their products or labelling, if there are new ingredients, dosages, or warnings (USFDA, 2016). So make a point of reading the label and the package insert each time you use a product, even if you’ve bought it before. If you still have questions, ask your pharmacist or other healthcare professional for advice.

About SMASA

The Self-Medication Manufacturers Association of South Africa (SMASA) aims to promote self-care and to enable consumers to responsibly and appropriately self-medicate and self-treat primary ailments where possible. As such, SMASA represents companies involved in the provision, distribution and sale of healthcare products. SMASA also engages actively in legislative, regulatory and policy development.

References 

1. Anderson, G, ‘Judge a medicine by its label’, 2012.
Available at: http://www.profmed.co.za/News-Blog/Blog/Judge-a-medicine-by-its-label
Accessed 18 April 2017.

2. Essentials, ‘Medicine schedules in South Africa: what do they REALLY mean?’, 2016.
Available at: http://www.essentials.co.za/lifestyle/medicine-schedules-what-do-they-really-mean
Accessed 19 April 2017.

3. The Medicines Control Council (MCC), ‘Health & Democracy: Developing, registering and using medicines’ Section 27, 2010.
Available at: https://section27.org.za/wp-content/uploads/2010/04/Chapter13.pdf
Accessed 18 April 2017.

4. US Food and Drug Administration (USFDA), ‘The Over-the-Counter Medicine Label: Take a Look’ 2016.
Available at: https://www.fda.gov/drugs/resourcesforyou/ucm133411.htm
Accessed 18 April 2017.