PRIMARY PRODUCT REGISTRATION

PRODUCT NAME

Dextromethorphan HBr BP 20mg/ Phenylephrine HCL BP 10mg/ Triprolidine HCL

BP 2.5mg
Oral Solution

SUBMITTED BY
EVEREST Pharmaceuticals Ltd.
Kanchpur BSCIC, Sonargaon, Narayanganj
BANGLADESH

Page 1 of 5
 FORM DA – 1/88

APPLICATION FORM FOR THE REGISTRATION OF DRUGS

(WHICH ARE INCLUDED AS MONOGRAPH IN USP/USPC/USP-NF/INT.PH.OR ALREADY
INTRODUCED IN BANGLADESH)

01. Name and address of the Manufacturer

EVEREST Pharmaceuticals Ltd.
Kanchpur BSCIC, Sonargaon, Narayanganj

02. Manufacturing Licence Number

a) Biological :178
b) Non-Biological :336

03 Name of the Drugs

a) Generic Name : Dextromethorphan HBr BP 20mg/ Phenylephrine HCL BP 10mg/ Triprolidine HCL
BP 2.5 mg.
b) Name under which the drug is proposed to be sold: To be submitted at the time of inclusion.

04. Product Data Sheet

a) Presentation :
Each 5 ml contains Dextromethorphan HBr BP 20mg/ Phenylephrine HCL BP 10mg/ Triprolidine HCL BP 2.5
mg.

b) Uses:
This preparation is indicated for the symptomatic relief of upper respiratory tract disorders
accompanied by non-productive cough which benefits from the administration of a nasal
decongestant, a histamine H1-receptor antagonist and an antitussive combination.

c) Dosage and Administration:

Adults & Children over 12 years: 1 teaspoonful 4 times a day.
6-12 years: 1/2 teaspoonful 4 times a day.

A physician's advice should be obtained before administering this combination to children less than 6
years.
Take with or without food. Take with food if it causes an upset stomach. Measure liquid doses
carefully. Use the measuring device that comes with this medicine.
d) Contraindications:
This combination is contraindicated in patients with a known hypersensitivity to Dextromethorphan,
Phenylephrine or Triprolidine as well as in persons under treatment with Monoamine Oxidase
Inhibitor within 2 weeks of stopping such treatment.
e) Precautions:
This combination may cause drowsiness. It may impair the patient’s ability to drive and also to use
Page 2 of 5
machineries. Although there are no objective data, users of this syrup should avoid the concomitant
use of alcohol or other centrally acting sedatives. As with other sympathomimetic agents caution
should be exercised in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated
intraocular pressure and prostatic enlargement. This combination should not be used for persistent or
chronic cough such as occurs with smoking, asthma, or emphysema or where cough is accompanied
by excessive secretion unless directed by a physician.

f) Side Effects
Side effects of Dextromethorphan appears to be rare and may include drowsiness. Prostatic
enlargement could have been an important predisposing factor.
g) Precautions & Warnings
This combination may cause drowsiness. It may impair the patient’s ability to drive and also to use
machineries. Although there are no objective data, users of this syrup should avoid the concomitant
use of alcohol or other centrally acting sedatives. As with other sympathomimetic agents caution
should be exercised in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated
intraocular pressure and prostatic enlargement. This combination should not be used for persistent or
chronic cough such as occurs with smoking, asthma, or emphysema or where cough is accompanied
by excessive secretion unless directed by a physician.
h) Package quantities:
To be submitted at the time of inclusion.

05.
Technical Data
a) Composition/Formula
Ingredients Specifications Quantity/ Function of
Tablet Excipients
Active Ingredient

Excipients

Coating Materials

Page 3 of 5
 * Solvent does not appear in the final product.

b) Manufacturing Instructions:

6. a) Number of manufacturer already manufacturing this product in Bangladesh:

N/A

b) Estimated market of this product in Bangladesh:

N/A

c) Control data for the active ingredient:

Dextromethorphan HBr BP 20mg/ Phenylephrine HCL BP 10mg/ Triprolidine HCL BP 2.5mg

d) Stability data:
Stability data is to be submitted at the time of inclusion.
e) Proposed shelf life:
Stability data is to be submitted at the time of inclusion.

7. a) Proposed Maximum Retail Price ( MRP ):

As fixed by the government of Bangladesh.
b) Estimated price per dose per day treatment & cost for the recommended courses of
treatment:

All depends on the prescription recommended by the physician.

08. a) Particulars of Head of Production

Full Name : Shah Galib Eftekhar

Qualification : M. Pharm.
Date of Joining in the applicant Company : 02.11.2019
Total experience in the Pharmaceutical Industries: 9 Years
Registration No. : A-5728

Signature : _________________
Page 4 of 5
b) Particulars of Head of Quality Assurance

Full Name : Md. Ruknuzzaman Rony

Qualification : M. Pharm.
Date of Joining in the applicant Company : 05.05.2019
Total experience in the Pharmaceutical Industries: 14 Years
Registration No. : A-2754

Signature : _________________

09 : Date of Submission :

Page 5 of 5