CALMYLIN ACE 10 MG / 5 ML
CODEINE PHOSPHATE : 10 MG / 5 ML PHENIRAMINE MALEATE : 7.5 MG / 5 ML GUAIFENESIN : 100 MG / 5 ML · DIN 02198630 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is CALMYLIN ACE?
CALMYLIN ACE 10 MG / 5 ML contains CODEINE PHOSPHATE : 10 MG / 5 ML PHENIRAMINE MALEATE : 7.5 MG / 5 ML GUAIFENESIN : 100 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02198630, held by TEVA CANADA LIMITED, supplied as SYRUP for ORAL administration. Health Canada currently lists it as marketed, status dated 16-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 ACE used for?
Temporary expectoration and control of cough associated with inflamed mucosa in adults.
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 | 02198630 |
|---|---|
| Brand name | CALMYLIN ACE |
| Generic / active ingredient | CODEINE PHOSPHATE : 10 MG / 5 ML PHENIRAMINE MALEATE : 7.5 MG / 5 ML GUAIFENESIN : 100 MG / 5 ML |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 10 MG / 5 ML |
| Dosage form | SYRUP |
| Route of administration | ORAL |
| Schedule | NARCOTICS (CDSA I) |
| ATC code | R05FA02 OPIUM DERIVATIVES AND EXPECTORANTS |
| AHFS class | 92:01.00* ; See footnote |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 16-Apr-2013 |
| Original market date | 1996-12-04 00:00:00 |
How is it administered?
Adults: 5 mL to 10 mL every 6 hours. Not indicated for patients under 18 years of age. Use lowest effective dose for shortest period.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in text provided (refers to Storage and Stability section).
How is it supplied?
Not explicitly detailed in text provided (refers to Dosage Forms, Composition and Packaging section).
Contraindications
Hypersensitivity; GI obstruction; asthma/COPD; respiratory depression; ultra-rapid CYP2D6 metabolizers; children <12; children <18 post-tonsillectomy; MAOIs; pregnancy/breast-feeding.
Warnings and precautions
Risk of addiction, abuse, misuse; life-threatening respiratory depression; fatal if accidentally ingested by children; risk of death in ultra-rapid metabolizers; avoid alcohol.
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 | 12.5 MG / 5 ML | SYRUP | TEVA CANADA LIMITED | MARKETED | DIN 00535230 |
| 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.