CALMYLIN 12.5 MG / 5 ML
DIPHENHYDRAMINE HYDROCHLORIDE : 12.5 MG / 5 ML CODEINE PHOSPHATE : 3.33 MG / 5 ML AMMONIUM CHLORIDE : 125 MG / 5 ML · DIN 00535230 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is CALMYLIN?
CALMYLIN 12.5 MG / 5 ML contains DIPHENHYDRAMINE HYDROCHLORIDE : 12.5 MG / 5 ML CODEINE PHOSPHATE : 3.33 MG / 5 ML AMMONIUM CHLORIDE : 125 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 00535230, held by TEVA CANADA LIMITED, supplied as SYRUP for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Apr-2013. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is CALMYLIN used for?
Suppression of dry, hacking cough, relief of nasal congestion (PSE version), symptomatic treatment of allergic reactions (Calmylin), and to loosen mucus/phlegm in cough due to colds.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 00535230 |
|---|---|
| Brand name | CALMYLIN |
| Generic / active ingredient | DIPHENHYDRAMINE HYDROCHLORIDE : 12.5 MG / 5 ML CODEINE PHOSPHATE : 3.33 MG / 5 ML AMMONIUM CHLORIDE : 125 MG / 5 ML |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 12.5 MG / 5 ML |
| Dosage form | SYRUP |
| Route of administration | ORAL |
| Schedule | NARCOTICS (CDSA I) |
| ATC code | R05FA02 OPIUM DERIVATIVES AND EXPECTORANTS |
| AHFS class | 48:08.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 24-Apr-2013 |
| Original market date | 1981-12-31 00:00:00 |
How is it administered?
Adults 12+: 10 mL every 3-4 hours (Calmylin) or every 4 hours (Calmylin PSE). Maximum 4 doses per day. Do not co-administer with same medicinal ingredients.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store between 15-30°C.
How is it supplied?
Bottles of 100 mL, 250 mL and 350 mL.
Contraindications
Hypersensitivity to components; pre-existing respiratory depression. CALMYLIN PSE WITH CODEINE: also contraindicated with MAO inhibitors or within 3 weeks of stopping them.
Warnings and precautions
Codeine is habit forming. May cause respiratory depression. Caution in patients with asthma, head injury, seizures, or glaucoma. Ultra-rapid metabolizers risk morphine overdose.
What can be used instead?
Other Canadian products sharing ATC code R05FA02 OPIUM DERIVATIVES AND EXPECTORANTS. 25 of 156 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| BENYLIN EXTRA STRENGTH COUGH & CHEST CONGESTION | 200 MG / 5 ML | SYRUP | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | MARKETED | DIN 02265419 |
| BENYLIN EXTRA STRENGTH COUGH & CHEST CONGESTION WITH WARMING SENSATION | 15 MG / 5 ML | SYRUP | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | MARKETED | DIN 02003317 |
| BENYLIN EXTRA STRENGTH COUGH COMPLETE | 200 MG / 5 ML | SYRUP | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | MARKETED | DIN 02265400 |
| BENYLIN EXTRA STRENGTH FOR PEOPLE WITH DIABETES | 15 MG / 5 ML | SYRUP | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | MARKETED | DIN 02436485 |
| BENYLIN EXTRA STRENGTH MUCUS & PHLEGM PLUS COUGH CONTROL | 15 MG / 5 ML | SYRUP | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | MARKETED | DIN 02320959 |
| BENYLIN REGULAR STRENGTH COUGH PLUS CHEST CONGESTION RELIEF | 15 MG / 5 ML | SYRUP | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | MARKETED | DIN 01944762 |
| CALMYLIN ACE | 10 MG / 5 ML | SYRUP | TEVA CANADA LIMITED | MARKETED | DIN 02198630 |
| CALMYLIN PSE WITH CODEINE | 3.3 MG / 5 ML | SYRUP | TEVA CANADA LIMITED | MARKETED | DIN 02172917 |
| COUGH & CHEST CONGESTION | 20 MG / 20 ML | SYRUP | JUNO OTC INC | MARKETED | DIN 02539195 |
| COUGH & COLD RELIEF EXTRA STRENGTH | 200 MG / 5 ML | SYRUP | CRLS | MARKETED | DIN 02540800 |
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.