FIORINAL 50 MG
BUTALBITAL : 50 MG ACETYLSALICYLIC ACID : 330 MG CAFFEINE : 40 MG · DIN 00226327 · ARALEZ PHARMACEUTICALS CANADA INC
Health Canada status: MARKETED
What is FIORINAL?
FIORINAL 50 MG contains BUTALBITAL : 50 MG ACETYLSALICYLIC ACID : 330 MG CAFFEINE : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 00226327, held by ARALEZ PHARMACEUTICALS CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 21-Jan-2020. 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 FIORINAL used for?
Indicated for the relief of tension-type headache. Not recommended for multiple recurrent headaches due to risk of medication overuse headache.
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 | 00226327 |
|---|---|
| Brand name | FIORINAL |
| Generic / active ingredient | BUTALBITAL : 50 MG ACETYLSALICYLIC ACID : 330 MG CAFFEINE : 40 MG |
| Manufacturer | ARALEZ PHARMACEUTICALS CANADA INC |
| Strength | 50 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | CONTROLLED DRUGS (CDSA IV) |
| ATC code | N02BA71 ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS |
| AHFS class | 28:08.04.24 ; 28:24.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 21-Jan-2020 |
| Original market date | 1971-12-31 00:00:00 |
How is it administered?
1 or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Extended use is not recommended due to habit-forming potential.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text.
How is it supplied?
Not explicitly detailed in provided text (mentions 'Capsules' and 'USP').
Contraindications
Hypersensitivity to ASA, caffeine, or butalbital; hemorrhagic diathesis; nasal polyps/angioedema/bronchospasm to NSAIDs; peptic ulcer; porphyria; history of drug/alcohol abuse; 3rd trimester pregnancy.
Warnings and precautions
Butalbital is habit-forming and potentially abusable. Risk of medication overuse headache. ASA can cause anaphylaxis and serious GI bleeding. Risk of Reye's syndrome in young adults.
What can be used instead?
Other Canadian products sharing ATC code N02BA71 ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS. 5 of 14 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 | 40 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02554690 |
| TEVA-TECNAL | 50 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 00608211 |
| TEVA-TECNAL | 50 MG | CAPSULE | TEVA CANADA LIMITED | MARKETED | DIN 00608238 |
| TRIANAL TABLET | 330 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 01971409 |
| 282 MEP TAB | 30 MG | TABLET | MERCK FROSST CANADA & CIE, MERCK FROSST CANADA & CO. | CANCELLED POST MARKET | DIN 00108316 |
| EQUAGESIC TABLETS | 75 MG | TABLET | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | DIN 02041804 |
| FIORINAL TAB | 50 MG | TABLET | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | DIN 00275328 |
| PMS-PHARNAL CAPSULES | 40 MG | CAPSULE | PHARMASCIENCE INC | CANCELLED PRE MARKET | DIN 02232988 |
| PMS-PHARNAL TABLETS | 50 MG | TABLET | PHARMASCIENCE INC | CANCELLED PRE MARKET | DIN 02232989 |
| PMS-PHARNAL-C 1/4 CAPSULES | 15 MG | CAPSULE | PHARMASCIENCE INC | CANCELLED PRE MARKET | DIN 02232985 |
Who else supplies ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS appears in 11 registered pack listings across 2 markets, published on 2 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.