APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 15 MG
CODEINE PHOSPHATE : 15 MG CAFFEINE : 40 MG ACETYLSALICYLIC ACID : 330 MG BUTALBITAL : 50 MG · DIN 02554615 · APOTEX INC
Health Canada status: MARKETED
What is APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4?
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 15 MG contains CODEINE PHOSPHATE : 15 MG CAFFEINE : 40 MG ACETYLSALICYLIC ACID : 330 MG BUTALBITAL : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02554615, held by APOTEX INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 08-May-2025. 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 APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 used for?
Indicated for the relief of tension-type headache 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 | 02554615 |
|---|---|
| Brand name | APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 |
| Generic / active ingredient | CODEINE PHOSPHATE : 15 MG CAFFEINE : 40 MG ACETYLSALICYLIC ACID : 330 MG BUTALBITAL : 50 MG |
| Manufacturer | APOTEX INC |
| Strength | 15 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | NARCOTICS (CDSA I) |
| ATC code | N02AA79 CODEIN, COMBINATIONS WITH PSYCHOLEPTICS |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 08-May-2025 |
How is it administered?
Capsules must be swallowed whole. Dosage should be the lowest effective dose for the shortest duration. Not recommended for patients under 18 years of age.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section).
How is it supplied?
Not explicitly detailed in provided text (refers to DOSAGE FORMS, COMPOSITION AND PACKAGING section).
Contraindications
Hypersensitivity to ASA, caffeine, codeine, or butalbital; GI obstruction; asthma; respiratory depression; pregnancy/breast-feeding; children <18 for tonsillectomy; CYP2D6 ultra-rapid metabolizers.
Warnings and precautions
Risk of addiction, abuse, misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; risks with benzodiazepines/alcohol; ASA-related bleeding/Reye's syndrome.
What can be used instead?
Other Canadian products sharing ATC code N02AA79 CODEIN, COMBINATIONS WITH PSYCHOLEPTICS. 6 of 17 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 |
|---|---|---|---|---|---|
| APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/2 | 50 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02554623 |
| FIORINAL-C 1/2 | 330 MG | CAPSULE | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | DIN 00176206 |
| FIORINAL-C 1/4 | 40 MG | CAPSULE | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | DIN 00176192 |
| TEVA-TECNAL C 1/2 | 40 MG | CAPSULE | TEVA CANADA LIMITED | MARKETED | DIN 00608181 |
| TEVA-TECNAL C 1/4 | 40 MG | CAPSULE | TEVA CANADA LIMITED | MARKETED | DIN 00608203 |
| PHENAPHEN NO 2 CAP | 16.2 MG | CAPSULE | AYERST LABORATORIES | CANCELLED POST MARKET | DIN 01909290 |
| PHENAPHEN NO 3 CAP | 16.2 MG | CAPSULE | AYERST LABORATORIES | CANCELLED POST MARKET | DIN 01909312 |
| PHENAPHEN NO 4 CAP | 64.8 MG | CAPSULE | AYERST LABORATORIES | CANCELLED POST MARKET | DIN 01909304 |
| PHENAPHEN NO.2 CAP | 16.2 MG | CAPSULE | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | DIN 02042851 |
| PHENAPHEN NO.3 CAP | 325 MG | CAPSULE | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | DIN 02042878 |
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.
Request a quote for APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4
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.