(i) the description of the drug as required in regulation 16 of these Regulations,
(ii) clinical pharmacology,
(iii) indications and usage,
(iv) contraindications,
(v) Interactions,
(vi) warnings e.g. use in pregnancy, lactation etc.,
(vii) precautions,
(viii) adverse reactions,
(ix) drug abuse and dependence (where applicable),
(x) symptoms of overdose and antidote,
(xi) dosage and administration,
(xii) the preparation for use (shaking, dilution, etc.),
(xiii) presentation,
(xiv) storage condition, and
(xv) any other information;
(c)
18.
no prescription drugs shall bear on its package label any statement, pictorial or
representations of the indications of the drug .
Over-the-counter Drugs Labeling, etc.
(1) In addition to compliance with the provisions of regulations 1 to 15 of these
Regulations, the following shall apply:(a)
the outer and inner labels of over-the-counter drugs shall be properly labelled
and shall bear the following information:(i)
the brand name (where applicable),
(ii)
the generic or common name,
(iii)
quantitative list of all active ingredients,
(iv)
indications for the drug,
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