(v)
the net content of the drug in terms of weight, measure or numerical count,
(vi)
the name and address of the manufacturer,
(vii)
lot or batch number,
(viii) adequate directions for safe use of the drug,
(ix)
dosage including amounts for use in specific age groups,
(x)
route and frequency of administration,
(xi)
warnings e.g. use in pregnancy, lactation etc.,
(xii)
contra-indications,
(xiii) side effects,
(xiv)
instruction for use (shaking, dilution, refrigeration etc.),
(xv)
a statement to the effect that a physician should be consulted if symptoms
persists for over the counter drugs that are self-limiting e.g. analgesics,
cough remedies etc.,
(xvi)
the statement in bold: “For external use only” for topical drug products
not intended for ingestion, or “For rectal or vaginal use only” etc. as
appropriate,
(xvii) a statement “For Veterinary use only” if for veterinary use and the
withdrawal period shall also be distinctly stated;
19.
(b)
where all the information required in this Regulation may not be contained on the
labels of the over-the-counter drugs, they shall be accompanied by a leaflet insert;
and
(c)
no person shall label over-the-counter drugs as treatment, preventive or cure for
any of the diseases, disorders or abnormal states as identified in Schedule I of
Food and Drugs Act Cap 150 of the Laws of the Federation of Nigeria1990.
Penalty.
(1) A person who contravenes a provision of these Regulations is guilty of an offence and
liable on conviction:(a)
in case of an individual, to imprisonment for a term not exceeding two years or to
a fine not exceeding N50,000 or to both fine and imprisonment; and
(b)
in case of a body corporate, to a fine not exceeding N100,000.
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