Lesson III:

OTC DRUGS

The headings are similar under prescription drugs.

 The products intended for external use, the statement “For
External Use Only” printed in red color shall appear on the inner
and outer label of the container.
The warning statement should appear on the inner and outer label
of the product.
ADDEDUM FOR BOTH Example” Warning: Keep Out of Reach of Children”
PRESCRIPTION AND
All information required to appear on a label must be clearly and
OTC DRUGS prominently displayed.
The information should be readable with normal vision without
straining.
The color contrast, the position and spacing of the information are
to be taken into consideration.
  When the inner label of a drug is too small to accommodate all the
information required, it should contain at least the following:
 a. the proper name of the drug
 b. the category
LABELING OF  c. the potency
DRUGS IN  d. net content
SMALL  e. route of administration
CONTAINERS  f. name and address of manufacturer/distributor
 g. lot number of the drug
 h. expiration
 i. registration number of the drug
  Package Insert is intended to provide authoritative and objective guides
to the medical professionals who have the capacity by training and
authorized by law to interpret the information, to prescribe or
administer the drug safely for the purposes for which they are intended.
 The package insert shall contain information applying only to the
BFAD product and its substances.
GUIDELINES  To be included are:
 1. Name of the product
IN PREPARING  2. Formulation
PACKAGE  3. Description of the product
INSERTS  4. Pharmacology
 5. Indications
 6. Contra-indications
 7. Precautions
 8. Adverse Reaction
 9. Dosage and Mode of Administration
 10. Symptoms and Treatment of Over- dosage
 11. Warnings
 12. Information for the patient
 13. Availability
 14. Storage Condition
 15. Manufacturer and Distributor
 16. The date of the latest revision of the package insert
REMINDER
Quiz # 1 MT
next Meeting
(30 items)