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HSA Approval

RHINATHIOL PROMETHAZINE SYRUP

SIN02613P

RHINATHIOL PROMETHAZINE SYRUP

RHINATHIOL PROMETHAZINE SYRUP

April 21, 1989

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantOPELLA HEALTHCARE SINGAPORE PTE. LTD.
Licence HolderOPELLA HEALTHCARE SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore Classification

Formulation Information

SYRUP

**3\. How to take Rhinathiol Promethazine Syrup** **Dosage and administration** This drug is contra-indicated in children less than two years of age. It should be used with caution in children 2 years and above. Dosage: For adults and children aged over 2 years only. Adults 15 ml three to four times a day. Children 2–5 years of age: 2.5 ml to 5 ml four times a day. 6–12 years of age: 7.5 ml to 12.5 ml three times a day. 12–15 years of age: 12.5 ml to 15 ml three times a day. Mode or route of administration: oral route. If an infant develops a cough, consult your doctor. Wash the measuring-spoon after each use. IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR’S OR PHARMACIST’S ADVICE. THIS DRUG HAS BEEN PRESCRIBED FOR YOU PERSONALLY IN A SPECIFIC SITUATION: IT MAY NOT BE SUITABLE FOR OTHER CASES. DO NOT ADVISE ANYONE ELSE TO TAKE IT. Treatment must be short (a few days) and only at times when coughing occurs. **If you take more Rhinathiol Promethazine Syrup than you should** Contact your doctor or the emergency services immediately. Rhinathiol Promethazine overdose may cause seizures (especially in children), impaired alertness and coma. **If you forget to take Rhinathiol Promethazine Syrup** Do not take a double dose to make up for the forgotten dose.

ORAL

Medical Information

**1\. What Rhinathiol Promethazine Syrup is and what it is used for** This drug contains promethazine (an antihistamine) and carbocisteine. It is recommended for the alleviation of unproductive and irritative coughs in adults and children aged 2 years and above, particularly when coughing occurs at night.

**2\. What you need to know before you take Rhinathiol Promethazine Syrup** If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Do not take Rhinathiol Promethazine Syrup - infants (under 2 years of age) due to the risk of worsening of bronchial congestion - if you are allergic to any of the active substances (promethazine, carbocisteine) or any of the other ingredients of this medicine listed in section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ - if you have previously or recently experienced agranulocytosis (a major drop in the number of white blood cells in the blood) - if you have difficulty urinating due to prostate or other problems - if you are at risk of certain types of glaucoma (increased pressure inside the eye) - if you are breast-feeding This medicine **MUST NOT BE USED** during pregnancy. CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE.

R06AD52

promethazine, combinations

Manufacturer Information

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Unither Liquid Manufacturing

Active Ingredients

CARBOCISTEINE

2 g/100 ml

Carbocisteine

PROMETHAZINE HCl

0.05 g/100 ml

Promethazine

Documents

Patient Information Leaflets

RHINATHIOL PROMETHAZINE SYRUP PIL.pdf

Approved: February 9, 2021

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