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Paracetamol, Caffeine & Phenylephrine Hydrochloride Tablets

Composition per tablet: Paracetamol 500 mg + Caffeine Anhydrous 30 mg + Phenylephrine Hydrochloride 10 mg.

Dosage form: Tablet; coating and appearance to be confirmed from the approved label.

Category: Cold & Flu / Analgesic formulations

Therapeutic category: Analgesic, antipyretic, caffeine adjuvant, decongestant ingredient.

SKU: paracetamol-caffeine-phenylephrine-hcl-tablets

Categories: Tablets Manufacturer, Uncategorized

Product Information

Paracetamol, Caffeine & Phenylephrine Hydrochloride 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.

Description

Manufacturing company: Healthy Life Pharma Pvt. Ltd. (facility certification and manufacturing arrangements to be verified).

Export partner: Healthy Inc (export status and market authorisations to be verified).

1. Product Introduction

This three-ingredient formulation combines paracetamol for fever and pain, caffeine as a stimulant and analgesic adjuvant, and oral phenylephrine hydrochloride, a sympathomimetic traditionally included in cold medicines as a decongestant. The supplied formula is 500 mg / 30 mg / 10 mg per tablet.

Regulatory note: Evidence does not support oral phenylephrine at standard OTC doses as an effective nasal decongestant. Its regulatory status and permitted claims vary by country. Avoid describing this combination as proven to unblock the nose or as guaranteed “non-drowsy” relief.

2. Product Specifications

Product NameParacetamol, Caffeine & Phenylephrine Hydrochloride Tablets
CompositionParacetamol 500 mg + Caffeine Anhydrous 30 mg + Phenylephrine HCl 10 mg
Dosage FormTablet; film-coating status subject to actual approved specification
Therapeutic ClassAnalgesic / Antipyretic / Stimulant adjuvant / Sympathomimetic ingredient
Pharmacopoeial StandardConfirm applicable IP/BP/USP monographs and finished-product specification
Shelf LifeAs supported by product-specific stability data
PackagingBlister/strip configuration subject to approved pack specification

3. Manufacturing Technology

Development should address blend uniformity for the lower-dose caffeine and phenylephrine components, API compatibility, moisture exposure, and reproducible disintegration and dissolution. Granulation method, excipients, coating and packaging must be selected from validated development and stability data rather than assumed.

4. Quality Assurance

Product-specific quality controls should include identification and assay of all three active ingredients, content uniformity, dissolution/disintegration as applicable, related substances including relevant paracetamol impurities, microbial quality where required, and stability in the proposed market pack. Acceptance limits must follow the approved specification; fixed universal assay or release percentages should not be claimed without evidence.

5. Pharmacology and Intended Use

  • Paracetamol: Relieves pain and reduces fever.
  • Caffeine: Central nervous system stimulant; may enhance analgesia in certain combinations.
  • Phenylephrine HCl: Alpha-adrenergic agonist. Oral efficacy for nasal congestion at conventional OTC doses is not established.

Any cold-and-flu indication or marketing statement must be supported by the approved label in the destination market. This product does not treat the underlying viral infection.

6. Export and Regulatory Support

Registration may require a country-specific formulation assessment, quality dossier, stability data, artwork and approved indications. CTD/ACTD, COA, FSC and COPP availability should be confirmed with the manufacturer. Oral phenylephrine regulatory developments require particular review before export or OTC promotion.

7. Frequently Asked Questions

Q: What is the stated composition?
A: Paracetamol 500 mg, Caffeine Anhydrous 30 mg and Phenylephrine Hydrochloride 10 mg per tablet.

Q: Is it guaranteed to be non-drowsy?
A: No. The absence of a sedating antihistamine does not guarantee alertness; individual reactions vary, and caffeine can cause restlessness.

Q: Does oral phenylephrine reliably relieve a blocked nose?
A: Clinical evidence has raised substantial concerns about its effectiveness at standard oral OTC doses. Claims must follow current local regulatory requirements.

Q: Can it be combined with another cold medicine?
A: Check all ingredients first. Taking multiple paracetamol-containing medicines can cause an accidental overdose.

8. Dosage and Administration

Use only according to the locally approved product label or a qualified clinician's instructions. Do not apply an assumed tablet frequency or maximum daily tablet count without checking the approved strength, age restrictions, other medicines and patient factors.

9. Side Effects and Precautions

  • Paracetamol: Excess dosing may cause severe liver injury; avoid duplicate paracetamol products.
  • Caffeine: Insomnia, nervousness, tremor and palpitations; consider other caffeine intake.
  • Phenylephrine: Potential blood-pressure and cardiovascular effects; review hypertension, heart disease, thyroid disease and interacting medicines, including MAO inhibitors.
  • Pregnancy, children and chronic illness: Seek product-specific medical advice; age limits and restrictions vary by market.

10. Storage Instructions

Store as stated on the approved product label, in the original pack and protected from inappropriate heat and moisture. Exact temperature limits and expiry must be supported by stability data.

For informational B2B product presentation only. Claims, regulatory status, indications, dosage, certification and manufacturing details require verification before publication or distribution.