Presentation about OTC Drugs, their types, significance, advise about prescribing them, OTC dugs available in market and FDA review of these drugs.

1. Presentation
On
OverThe Counter Drugs [OTC]
Amity University, NOIDA
Amity Institute of Pharmacy
BY: UNNATI GARG

2. INTRODUCTION
• OTC Drugs are those drugs, which can be sold without
prescription, thus is also called as non prescription drugs.
• In case of these drugs, the companies directly approach the
consumer through mass media like television, newspaper
etc.
• Examples of these drugs are: Saridon, crocin, vicks action
500, anacin, etc.
• These drugs are sold without any prescription. Some of
these are used to relieve aches, pain of itches some prevent
or cure diseases like tooth decay and athlete’s foot.

3. Types of OTC
Drug Products
Pain Reliever: The OTC products that relieve headache, fever
or muscle aches are not all the same. In the local drug store
or pharmacy they are either nonsteroidal or anti-
inflammatory drugs. Example: Ibuprofen, Aspirin, Naproxen
Anti-Histamines: These work by blocking the receptor that
triggers itching, nasal irritation, sneezing and mucous
production.These are of three types:
a. Diphenhydramine: The medicine products such as
Banophen, Benadryl allergy and Diphenist.
b. Bropheniramine: The medicine in products such as Dimetapp
allergy.
c. Chlorpheniramine:The medicine in products such as
Allerchor, chloamine and chlor-trimenton allergy.

4.  Decongestants:These work by narrowing blood vessels, in
the lining of nose.As a result less blood is able to flow
through the nasal area and swollen tissue inside the nose
shrinks. Pseudoephedrine is the only decongestant used as
OTC product.
 Cough Medicine:These are grouped into two types:
a. Anti-tussives:These block the cough reflex.
Dextromethorphan is common antitussive.
b. Expectorant:These make coughing more productive
in clearing the mucus from the airway.Guaifenesin is
the only expectorant used in OTC products.

5. Significance of OTC Drugs
• According to the FDA, the OTC labels should be more detailed as compared to prescription medicines
and should include the following information:
Product name
Active ingredient
Name and address of the manufacturer
Net qty of ingredients
Description of tamper resistant features
Indications for use
Directions and dosage instructions
Purpose
Warning and contra indication
Precaution on drug interaction
Batch number and expiry date

6. General advice about prescribing OTC
Drugs
1
Prescribe only
when necessary
and when
benefits are
likely to
outweigh the
risks.
2
Be particularly
careful when
recommending
non-
prescription
drugs.
3
Watch out for
potential drug-
drug
interaction
4
Some drugs
may be
excreted in
breast milk in
sufficient
amount to
cause distress
in nursing.
5
Discourage
chronic use of
non-
prescription
drugs.
6
Watch out for
drug abuse.

7. OTC Drugs used in market
1
OTC drugs used
to cure disease
of Alimentary
system.
Example:
Digene,
VoveranTab,
Digeplex syrup.
2
OTC drugs
used as
analgesics
and
antipyretics:
Analgin,
Crocin, Asprin
3
OTC drugs
used as
female
contraceptive
are: Pearl tab,
Mala-D &
SaheliTab.
4
OTC drugs
used for skin
treatment:
Ring guard
tube,
Betnovate N
5
OTC drugs
used in
amoeboisis
are: Flagyl
Tab, Zintac
Tab
6
OTC drugs
used to cure
respiratory
disease are:
Ambrolite-D,
Ambrolite-S
7
OTC drugs
used to cure
Vitamin and
Mineral
deficiency are:
Becadexamin
Cap., Revital
Cap./Syrup

8. FDA OTC
Drug review
The principal focus of the
review is to establish the
safety, effectiveness and
proper labeling of OTC
medications.
The original panels review
medication in various
product categories and
classify the ingredients into
3 categories:
Category I: Ingredients are
generally recognized as safe and
effective for claimed therapeutic
indication.
Category II: Ingredients are not
generally recognized as safe and
effective or have unacceptable
indications.
Category III: Because of
insufficient data, the FDA cannot
classify these ingredients into
category I and II.