Cough and Cold
– a UAE survey
By Dr Yasser Sharif and
Dr Sherif El Ghandour
Until recently, most cough and cold medications in the United Arab Emirates (UAE)
were sold as over the counter (OTC). Dispensing OTC medications allowed
pharmacists to sell cough and cold medications for any age group without
physician’s consultation. This practice was
common, despite the fact that many of
these products, especially those indicated
for children, are registered by the UAE -
Ministry of Health (MOH) as prescription
only medicines (POM).
Usually, the pharmacists rely on the
information which is listed on the label of
the product in regard to indications, doses,
and the age of the patient who can use the
This common practice raises a lot of
safety concerns, especially with the availability
of many cough and cold products,
which are manufactured by different pharmaceutical
companies inside and outside
of the UAE.
For instance, one might find two
different brands with exactly the same
active ingredients at the same strength;
however, the dosing instructions on their
respective labels are different. In one of
them, you may find in the dosage administration
section certain dose for a specific
age group, while the other similar product
explicitly contraindicates the product use
in the same age group.
These discrepancies arose due to products
approval by different regulatory
organizations from different countries. As
a result, these labels have created a great
deal of confusion for the physician, the
pharmacist, and consequently the patient.
In addition, due to the fact that most of
cough and cold products share common
active ingredients, there is a potential for
an overdose to occur. This can happen,
especially if a patient self administers more
than one cough and cold medication at
the same time for the same condition
without consultation. To demonstrate the
severity of this problem, in the United
States (from 2004 to 2005) an estimated
1,519 children aged less than 2 years were
treated in the emergency department for
adverse events, including overdoses, that
were associated with cough and cold
medications. Data for the UAE is
currently lacking regarding accidental
overdose in children from cough and cold
In response to the situation, the Health
Authority Abu Dhabi Poison and Drug
Information Center (HAAD-PDIC) took
the initiative to conduct a comprehensive
survey on all cough and cold products
which are available in community pharmacies
in the UAE to determine the
appropriateness of the packaging, accuracy
of labels, and safety of the ingredients.
The primary objective of the survey was
to identify those products with potential
risk on the public’s health and, subsequently,
take the appropriate regulatory
1. All cough and cold medications that
are available at community pharmacies
within the UAE were purchased for
analysis. Products that contained
codeine and dextromethorphan were
excluded from the survey as they are
not accessible without a controlleddrug
prescription as per the UAE pharmacy
2. The following information were
collected and analyzed using a spread
sheet; name of the product; dosage
form; ingredients’ class; decongestants,
antihistamines, expectorants, cough
suppressants, and miscellaneous ingredients
such as menthol, camphor, etc.;
and strength of each ingredient.
3. Another spread sheet was created to include only cough and cold syrups in
order to describe other criteria such as:
- Alcohol content
- Presence of child resistant cap
- Presence of measuring device which
is clearly marked and easy to use
- Active ingredients in regard to the
concentration and appropriateness
- Label instructions in regard to
complete information on age group
that can use the product and the
recommended daily doses for
different age groups
The total number of cough and cold medicines
that were screened for analysis were
105 products, covering all dosage forms;
tablets, syrup, nasal drops, and rubs.
Syrups represent 53% (56 products) of
the available products (Figure 1). Alcohol content
There were inconsistencies and lack of
clarity in about 2/3 of the screened syrup
products with regard to the alcohol
content, as follows: (Figure 2)
Alcohol content in cough and cold
products is a challenge, where the majority
of consumers in UAE may not prefer to
take alcohol containing medications, for personal or religious reasons.
consumers have the right to be notified
about the alcohol content in cough and
cold products. It was found that only 20%
of the screened products are alcohol free,
in addition to another 12% of the
where the alcohol content was specified.
On the rest of the products (67%),
either the alcohol is present, however,
without specifying the exact amount or
there is no mention at all whether it
contains alcohol or not. The US FDA
established – from safety perspective - the
maximum concentration limits for alcohol
as an inactive ingredient in OTC products
as follows; (table 1)
Therefore, it is highly recommended
that the alcohol presence should be clearly
stated as well as its concentration.
A major safety concern in the survey was
lacking of child–resistant cap in 77% of
the syrup products(Figure 3), which leads
to a high risk of accidental ingestion by
children, the FDA advises that caregivers
choose OTC cough and cold medicines
with child-resistant caps when available.
Another equally important safety issue is the
dose measuring device, which was missing in
41% of the screened products. Furthermore, when the measuring device is present,
inconvenient to measure the correct dose -
this was the case in another 30% of the
screened products (Figure 4). Measuring
devices enables the consumer to get the accurate
dose and, therefore, prevents errors in
dosing. According to the Australian regulatory
guidelines for OTC medicines 2003, “if
the recommended doses cannot be measured
using a readily available metric measuring
device, a suitable measuring device should be
provided in the pack”.
One product has promethazine (2.5 mg/5
ml) as an active ingredient, was found to
have dosing instructions for children who
are 1 year and older. It is well documented
that promethazine has been reported to
cause respiratory arrest in children less
than 2 years of age. The reports involved
children who received a wide range of
weight adjusted doses.
Another safety concern with this
product was that, the product container
was not child resistant. Therefore, HAAD
took immediate action and withdrew the
product from all community pharmacies in
the emirate of Abu Dhabi and subsequently,
from the whole UAE market with
the full cooperation of the manufacturer.
Strength of active ingredients
Another product was found to have pseudoephedrine
in extremely high concentration
(60 mg/5ml), which is the highest
among all of the MOH registered products.
This high concentration could be
extremely problematic as even a small
excess of the dose may lead to an overdose.
In addition, although the label of the
product clearly states, “Not recommended
for children less than 6 years old”, there is
an infant image on the outer box.
The presence of infant image on a product
that is not meant to treat pediatric patients
less than 6 years of age may cause consumers
to believe that the product can be given to
any pediatric age group, particularly if the
precautionary statement is not read or understood. HAAD contacted the manufacturer
who agreed to withdraw the product from
Abu Dhabi community pharmacies.
In addition to the above findings, there
are some other significant observations
with regard to labeling and packaging
included the following:
– Out of 56 products, only three products
(5.4%) were found to follow the standards
by the FDA for OTC products
including clarity of label instructions,
accurate and clearly stated doses, clearly
categorized age groups, the presence of
convenient measuring devices, and
contained child resistant caps[3, 6].
– 32 products (57%) are recommended
for use for children less than 2 years old.
Two products (3.5%) recommend the
use in children without specifying any age
– Three products (5.4%) have
misleading images, which may attract children
to drink them, especially in absence
of the parents’ supervision.
– One product (~2%) has the following
dosing instructions: (one teaspoonful every
3 hours), if this instruction is followed literally,
will definitely lead to overdose in children.
This product contains diphenhydramine
7 mg/5 ml, in addition to ammonium
chloride 67.5 mg/5 ml.
Eight products (14.3%) use inaccurate measuring term such as one quarter
teaspoon, (1.25 mL) for children dosing,
which is practically impossible to be measured
accurately by the average consumer.
Note: some of the products have more
than one safety concern; therefore the
total percentage does not add up to 100%
The main focus of this project has been
on the safety of cough and cold syrup
dosage forms since there is a lot of controversy
in regards to both the safety and efficacy
of these products in children less than
12 years of age. For those products which
have major risks for public health, HAAD
took immediate action and withdrew them
from pharmacies in Abu Dhabi.
During the survey, there were a lot of
changes worldwide in regard to safety
concerns for using cough & cold products
in children as shown in the table.
Cough & cold products are not suitable for
children younger than 6 years old. Due to
lack of efficacy and high risk of overdose,
we endorse the decision that was taken by
the UAE MOH to recommend against the
use of cough and cold products for children
younger than 6 years old. We believe that
this survey will be very helpful in the
process of standardisation of label information,
active ingredients, and safety measures
of cough and cold products nationwide.
Our next step at HAAD is to take
the initiative along with the MOH to
consider changes in labeled information
for cough & cold medications.
About the Authors
• Dr Yasser Sharif is Head of Medication
& Medical Product Safety at the Health
Authority - Abu Dhabi. Email:
• Dr Sherif El Ghandour is a Poison and
Drug Information Officer at the Health
Authority - Abu Dhabi
For more information visit: www.haad.ae/haaddeps/pdic
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Morb Mortal Wkly Rep 2007. 56: p. 1-4.
2. 21CFR328.10, Over-the-counter drug products
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of upload: 15th Aug 2010