DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)103. PARACETAMOL WITH CAFFEINE IN COMBINATIONThe following statement shall be included on the labels and in the packageinserts of products containing Paracetamol with Caffeine in combination:WARNINGAvoid other caffeine containing products. Too much caffeine may causerapid heart rate, nervousness or sleeplessness.Ask a doctor or pharmacist before use if you have high blood pressure,glaucoma, or overactive bladder syndrome.DO NOT exceed 8 tablets in 24 hours.DO NOT take more than the recommended dose unless advised by yourdoctor. Use the smallest effective dose. Taking more than the maximumdaily dose may cause severe or possibly fatal liver damage.DO NOT use with other drugs containing paracetamol.NOT recommended for children under 12 years104. PELARGONIUM SIDOIDESThe following warning shall be included on the labels and in the packageinserts of products containing Pelargonium Sidoides:WARNINGIn very rare cases, pelargonium sidoides may cause hypersensitivity reactions.105. PENICILLINThe following statement shall be included on the labels of products containingpenicillin:„Not to be used in patients with known hypersensitivity to Penicillin‟National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 404
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)106. PHENIRAMINEThe following statement shall be included on the label and in the packageinserts of liquid oral products containing Pheniramine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice inchildren 2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)107. PHENYLEPHRINEThe following statement shall be included on the labels and in the packageinsert of liquid oral products containing Phenylephrine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice inchildren 2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)108. PIRIBEDILPlease refer to DOPAMINERGIC INGREDIENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 405
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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