Product: Paracetamol, Caffeine and Phenylephrine Tablets
Proposed composition from supplied description: Paracetamol 500 mg + Caffeine 30 mg + Phenylephrine HCl 5 mg or 10 mg. Important: Neither triple-combination strength is confirmed by the supplied ingredient-by-ingredient label; verify against approved artwork before publication.
Category: Analgesic / Cold and Flu Formulations
Therapeutic class: Analgesic, Antipyretic, Caffeine Adjuvant, Sympathomimetic
SKU: paracetamol-caffeine-phenylephrine-tablets
Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations
Paracetamol, Caffeine & Phenylephrine Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturing company: Healthy Life Pharma Pvt. Ltd. (specific WHO-GMP certification and manufacturing arrangements require verification).
Export partner: Healthy Inc (export status and destination-market registrations require verification).
Paracetamol, Caffeine and Phenylephrine Tablets combine an analgesic/antipyretic, a stimulant adjuvant and an oral sympathomimetic ingredient. Paracetamol is used to reduce fever and relieve aches and headache. Caffeine can contribute to analgesic effects in certain combinations. Oral phenylephrine has historically been included in cold preparations, although evidence does not establish effectiveness at standard oral OTC doses for nasal congestion.
This page is intended for B2B product enquiries and formulation discussions. Final therapeutic claims, permitted strengths and classification depend on the approved product label and destination-country regulations.
| Product name | Paracetamol, Caffeine & Phenylephrine Tablets |
|---|---|
| Proposed strengths (not confirmed) | Paracetamol 500 mg + Caffeine 30 mg + Phenylephrine HCl 5 mg / 10 mg |
| Supplied source status | The ingredient-by-ingredient list contains four-component formulations with chlorpheniramine, not a verified three-component label. |
| Dosage form | Tablet; coating, shape and colour to be confirmed |
| Therapeutic category | Analgesic / Antipyretic / Stimulant adjuvant / Sympathomimetic ingredient |
| Pharmacopoeial standard | Verify individual APIs and finished-product specification against relevant IP/BP/USP requirements |
| Shelf life | To be established from stability studies; 36 months is unverified |
| Packaging | As per approved packaging specification and stability data |
Manufacturing development should address low-dose phenylephrine content uniformity, blend segregation, compatibility between the active ingredients, appropriate excipients, moisture control and validated tablet performance. High-shear mixing, wet granulation, film coating and specific binders should only be described as actual processes after batch records and master manufacturing instructions are checked.
Protective packaging is selected on the basis of stability studies, climatic conditions and destination-market requirements.
Quality assessment may include identification and assay of each API, dosage-unit uniformity, dissolution or disintegration as applicable, impurity testing, microbial quality where required and stability monitoring. Acceptance criteria must follow the approved finished-product specification rather than unsupported universal limits or guarantees of immediate symptom relief.
Paracetamol: provides relief of pain and fever. Caffeine: is a CNS stimulant and may act as an analgesic adjuvant. Phenylephrine: is an alpha-adrenergic agonist, but current evidence raises substantial concerns about oral phenylephrine's effectiveness as a nasal decongestant at commonly used OTC doses.
Claims such as “non-drowsy”, “clears blocked noses”, “40% stronger”, “safe for driving” or “fast relief within 15 minutes” should not be made without appropriate formulation-specific evidence and regulatory approval. This combination is not a treatment for the viral infection itself.
For contract manufacturing and export enquiries, buyers should request a current certificate of analysis, applicable GMP documentation, approved composition and artwork, product specification, stability information and market-specific registration dossier where available. CTD/ACTD, FSC and COPP availability should be confirmed before making a contractual or regulatory commitment.
Q: What is the proposed composition?
A: The supplied narrative proposes 500 mg paracetamol, 30 mg caffeine and 5 mg or 10 mg phenylephrine HCl; the original ingredient list does not independently confirm these triple-combination variants.
Q: Is this proven to clear nasal congestion?
A: No. Oral phenylephrine at standard OTC doses has not demonstrated convincing decongestant efficacy.
Q: Is it guaranteed not to cause drowsiness?
A: No. Absence of a sedating antihistamine does not guarantee alertness or fitness to drive.
Q: Can patients with high blood pressure use it?
A: Phenylephrine and caffeine may affect blood pressure or heart rate; clinical assessment and local product labelling are important.
Use only the dosage instructions on the approved product label or as prescribed by a qualified clinician. Do not infer dosing from other cold-and-flu tablets or assume that different phenylephrine strengths are interchangeable. Avoid combining with other medicines containing paracetamol. Age restrictions and maximum daily dose vary by formulation, jurisdiction and patient risk factors.
Paracetamol overdose may cause severe liver injury. Caffeine may cause insomnia, nervousness, tremor and palpitations. Phenylephrine can raise blood pressure and may be unsuitable in certain cardiovascular conditions, hyperthyroidism or with monoamine oxidase inhibitors. Check local contraindications, pregnancy and breastfeeding guidance, interactions and patient-specific factors before use. Seek urgent care for suspected paracetamol overdose, even if symptoms are initially absent.
Store according to the approved pack label and product-specific stability data. Protect from excessive moisture and heat where indicated. Keep medicines out of the reach of children.
Regulatory note: This B2B informational page is not a substitute for an approved package insert, product licence, medical advice or manufacturing validation. Confirm strengths, efficacy claims, GMP status and export documents before publishing.