Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SYRUP
**RECOMMENDED DOSAGE:** **Dhasedyl DM contains promethazine hydrochloride. It should not be used in the pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.** **Dhasedyl DM syrup is to be used with caution in children 2 years and older.** **Extreme care should be taken in giving an accurate dose of medicine because overdoses have been reported to cause serious adverse events. It is highly recommended that a measuring spoon or syringe (which can be obtained from the pharmacy) be used to administer doses.** To be administered orally. Children 2–6 years: 2.5ml 3 times a day. Children 6-12 years: 2.5 to 5ml 3 times a day. Adults: 5 to 10ml 3 or 4 times a day.
ORAL
Medical Information
**WHAT IS DHASEDYL DM SYRUP USED FOR?** Dhasedyl DM syrup contains: Dextromethorphan: an opioid derivative and cough suppressant for relieving non-productive cough. Promethazine: a sedating phenothiazine derivative antihistamine, which relieves symptoms of allergic condition and rhinitis. Ephedrine: has sympathomimetic effect which is used for symptomatic relief of nasal congestion. This formulation is used for temporary or short term (7 days) relief of symptoms of cough and cold. If symptoms persist, consult the physician. Dosage should not be increased if cough fails to respond.
Under **PRECAUTIONS** Do not take this medicine if you are allergic to any of the ingredients (promethazine, dextromethorphan, ephedrine) in this product. Do not take this medicine during pregnancy or breast feeding, before consulting your doctor or pharmacist. Do not take this medicine after the expiry date stated on the label. Do not take this medicine if you have liver disease, bronchial asthma, or receiving MAO (monoamine oxidase) inhibitors for conditions such as depression or Parkinson's disease.
R06AD52
promethazine, combinations
Manufacturer Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
PT. ACTAVIS INDONESIA
Active Ingredients
Documents
Package Inserts
Dhasedyl DM Syrup PI.pdf
Approved: October 14, 2021