(2) The packaged insert providing information concerning prescription drugs for human
use containing an approved non-nutritive sweetener as an inactive ingredient
shall bear a conspicuous declaration as to the identity and quantity of the non-nutritive
sweetener in milligram per dosage unit and shall also bear boldly and conspicuously
any precautionary warnings
for the non- nutritive sweetener as may be
prescribed by the Agency .
16. Warning for children.
The labels of all drugs shall state prominently a warning statement to the following
effect: “Keep this medicine out of reach of children”.
17.
Prescription drugs labeling, etc.
In addition to compliance with the provisions in paragraphs 1 to 15 of these Regulations,
the following shall apply:(a)
all prescription drugs shall be properly labelled with the information on the
package label as follows (i) the brand name (where applicable),
(ii) the generic or common name,
(iii) dosage form and strength,
(iv) listing of active ingredients,
(v) net content,
(vi) name and location address of manufacturer,
(vii) batch or lot number,
(viii) manufacture and expiry dates,
(ix) storage conditions,
(x) warning for children,
(xi) 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,
and
(xii) the statement “ For veterinary use only” if for veterinary only use and the
withdrawal Period shall also be distinctly stated;
(b)
the leaflet insert in all prescription drugs shall provide the following information
on the drug:6