In the pharmaceutical industry, the combination of Paracetamol, Phenylephrine HCl, Chlorpheniramine Maleate (CPM), and Caffeine is considered a Total Multi-Symptom Relief formulation.
As a pharmacist and manufacturer, I classify this as a “Complete Cold & Flu” treatment. Unlike the “Daytime” versions, the addition of CPM makes this an all-in-one solution that addresses the “wet” symptoms of a cold (runny nose and sneezing) in addition to pain, congestion, and lethargy.
Primary Clinical Uses
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Common Cold & Influenza: Comprehensive relief from fever, shivering, and body aches.
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Allergic Rhinitis: Specifically effective when allergies cause both congestion and a runny nose.
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Sinusitis: Reduces sinus pressure while drying up excessive mucus.
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Hay Fever: Relieves itchy/watery eyes, sneezing, and nasal blockage.
Quadruple Mechanism of Action (The 4-Way Attack)
Paracetamol (500 mg):
Action: Analgesic and Antipyretic.
Result: Blocks pain signals in the CNS and resets the hypothalamic heat-regulating center to reduce fever.
Phenylephrine HCl (5 mg – 10 mg):
Action: Decongestant ($\alpha_1$-adrenergic agonist).
Result: Constricts dilated blood vessels in the nasal mucosa, reducing swelling and opening the airways.
Chlorpheniramine Maleate (CPM) (2 mg – 4 mg):
Action: First-generation Antihistamine ($H_1$ receptor antagonist).
Result: Blocks the action of histamine, which stops sneezing, itching, and “dries up” a runny nose (rhinorrhea).
Caffeine (30 mg):
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Action: Analgesic Adjuvant & Mild Stimulant.
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Result: Accelerates the absorption of Paracetamol and helps counteract the drowsiness often caused by the CPM.
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The Manufacturer’s Perspective: Formulation & Export
From a production standpoint at your WHO-GMP facility in Mumbai, this formulation presents specific technical opportunities for your firm:
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The Stability of CPM: Chlorpheniramine is relatively stable, but the overall blend must be protected from moisture to prevent the Phenylephrine from degrading. We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions.
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Balancing the “Drowsiness” Factor: Although Caffeine is included to keep the patient alert, the CPM still has a sedative effect. As a firm owner, your Product Information Leaflet (PIL) should include a “Caution: May cause drowsiness” warning, which is a regulatory requirement for export to most Western and African markets.
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Market Positioning: On your digital and social media platforms, you can market this as a “Professional Strength” cold formula. It is highly sought after in B2B trading because it replaces the need for patients to buy three separate medicines.
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Dossier Availability: Our Mumbai facility provides full CTD/eCTD Dossiers to support international registration and supply to hospital and retail pharmacy chains.