Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Austell Pharmaceuticals (Pty) Ltd., 1 Sherborne Road, Parktown, Johannesburg, 2193, South Africa, Tel: +27 11 611 1400 or +27 860 287 835
AUSTIFEN-200 TABLETS.
AUSTIFEN-400 TABLETS.
AUSTIFEN-600 TABLETS.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. AUSTIFEN-200 TABLETS: White, circular, film-coated tablets, plain on both the sides. AUSTIFEN-400 TABLETS: White capsule shaped film-coated tablets, plain on both the sides. AUSTIFEN-600 TABLETS: White capsule shaped film coated tablets, plain on one side and breakline on the other side. |
AUSTIFEN–200 TABLETS:
Each film-coated tablet contains ibuprofen 200 mg.
Contains sugar: lactose monohydrate 8,00 mg.
AUSTIFEN-400 TABLETS:
Each film-coated tablet contains ibuprofen 400 mg.
Contains sugar: lactose monohydrate 16,00 mg.
AUSTIFEN–600 TABLETS:
Each film-coated tablet contains ibuprofen 600 mg.
Contains sugar: lactose monohydrate 24,00 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film coating: Hydroxypropyl cellulose |
AUSTIFEN-200 tablets:
Opaque Aluminium/PVC blister packs of 1 × 12, 2 × 12, 4 × 12, 7 × 12, 1 × 15, 1 × 16 and 3 × 14 tablets.
Bulk pack (White HDPE jars) of 1000 tablets.
AUSTIFEN-400 tablets:
Opaque Aluminium/PVC blister packs of 1 × 12, 2 × 12, 4 × 12, 7 × 12, 1 × 15, 1 × 16 and 3 × 14 tablets.
Bulk pack (White HDPE jars) of 1000 tablets.
AUSTIFEN-600 tablets:
Opaque Aluminium/PVC blister packs of 1 × 12, 2 × 12, 4 × 12, 7 × 12, 1 × 15, 1 × 16 and 3 × 14 tablets.
Bulk pack (White HDPE jars) of 1000 tablets.
Austell Pharmaceuticals (Pty) Ltd., 1 Sherborne Road, Parktown, Johannesburg, 2193, South Africa, Tel: +27 11 611 1400 or +27 860 287 835
AUSTIFEN-200 TABLETS: 42/3.1/0058
AUSTIFEN-400 TABLETS: 42/3.1/0059
AUSTIFEN-600 TABLETS: 42/3.1/0060
09 October 2009
| Drug | Countries | |
|---|---|---|
| AUSTIFEN | South Africa |
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