Source: Medicines Authority (MT) Revision Year: 2023 Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Daleron COLD3 325 mg/30 mg/15 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. The tablets are light green, oval and biconvex. Tablet length: approximately 15 mm. |
Each film-coated tablet contains 325 mg paracetamol, 30 mg pseudoephedrine hydrochloride and 15 mg dextromethorphan hydrobromide.
Excipient with known effect:
| Quinoline yellow (E104) |
| 0.08535 mg/tablet |
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Demorphan |
Dextromethorphan is a non-opioid antitussive drug. The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and δ-receptors. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA) receptors. |
|
| Paracetamol |
Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain. |
|
| Pseudoephedrine |
Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film-coating: Hypromellose (E464) |
Blister (Al foil, PVC/PVDC foil): 12 film-coated tablets (1 blister of 12 tablets), in a box.
Blister (Al foil, PVC/PVDC foil): 24 film-coated tablets (2 blisters of 12 tablets), in a box.
Not all pack sizes may be marketed.
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
MA982/02701
Date of first authorisation: 07th January 2022
| Drug | Countries | |
|---|---|---|
| DALERON COLD3 | Croatia, Lithuania, Malta, Romania |
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