This brand name is authorized in Nigeria.
The drug KOFDEX COUGH contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
YC2ZOM3Z8V - BROMHEXINE HYDROCHLORIDE
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Bromhexine is an expectorant used in the treatment of respiratory disorders associated with viscid or excessive mucus. Bromhexine is a synthetic derivative of the herbal active ingredient vasicine. It has been shown to increase the proportion of serous bronchial secretion, making it more easily expectorated. It is indicated as “secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport”. |
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2
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UNII
7355X3ROTS - DEXTROMETHORPHAN
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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. |
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3
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UNII
01Q9PC255D - AMMONIUM CHLORIDE
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4
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UNII
L7T10EIP3A - MENTHOL, UNSPECIFIED FORM
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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A11-100608 | Syrup | KOFDEX COUGH SYRUP SYRUP 4 mg/5 mL; 5 mg/5 mL; 50 mg/5 mL; 5 mg/5 mL 100ML | 83 NF-PP-246906 KOFDEX COUGH SYRUP Bromhexine & Dextromethorphan Cough Syrup Each 5ml contains: Dextromethorphan Hydrobromide 5mg, Bromhexine Hydrochloride 4mg, Ammonium Chloride 50mg, Menthol 2.5mg, Glycerin 1000mg, Ethanol 96% 450mg, Liquid Sorbitol 70% Non-crystallizing 2857mg, Sodium Benzoate 4mg, Citric Acid Monohydrate 5mg, Banana Flavor 0.0005ml, Vanilla Flavor 0.0007ml, Apple Green Color 0.138mg, Purified water ...qs.. 5ml. A11-100608 Drugs Nigerian Products 100ML OTC 1/19/2022 UNIQUE PHARMACEUTICALS LIMITED, KM 38, ABEOKUTA ROAD, VEEPEE INDUSTRIAL AVENUE, SANGO-OTA,OGUN STATE. 8097421000 mail@uniquepharm.com UNIQUE PHARMACEUTICALS LIMITED, 11, FATAI ATERE WAY, MATORI, MUSHIN, LAGOS., Nigeria | 21/12/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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R05CA10 | Combinations | R Respiratory system → R05 Cough and cold preparations → R05C Expectorants, excl. combinations with cough suppressants → R05CA Expectorants |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
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NG | Registered Drug Product Database | A11-100608 |
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