Paracetamol, Diclofenac Sodium & Caffeine Tablets

1. Product Introduction

Formulation note: “Diclofenac” in this product title refers specifically to Diclofenac Sodium 50 mg. Diclofenac Potassium is a different salt and must not be substituted in the composition or product label.

Strength clarification: The 500 mg / 50 mg / 30 mg formulation is the main supplied composition. A 325 mg paracetamol variant was mentioned separately but its complete three-ingredient formula is not confirmed. Do not label it as an available strength until the approved product specification is provided.

Paracetamol, Diclofenac & Caffeine Tablets combine an analgesic-antipyretic, a non-steroidal anti-inflammatory drug (NSAID), and a caffeine adjuvant. The composition provided is Paracetamol 500 mg + Diclofenac Sodium 50 mg + Caffeine Anhydrous 30 mg per tablet.

Healthy Life Pharma Pvt. Ltd. is presented as the manufacturer and Healthy Inc as the exporter for B2B product enquiries. Manufacturing status, certificates and market authorizations must be checked against current records before commercial publication. The combination is intended for markets where this fixed-dose formulation is specifically authorized; indications are determined by local approved labeling.

2. Product Specifications

3. Manufacturing Technology

Manufacture of a multi-ingredient tablet requires validated blending, content-uniformity controls, appropriate excipient compatibility studies, and process monitoring. Granulation, compression and any film coating should follow the approved master manufacturing record. The supplied description mentions buffers, super-disintegrants and coating systems; these are proposed process features, not verified site-specific practices.

Moisture-protective packaging may be considered based on validated stability and transport studies. Actual process, coating type and packaging require confirmation.

4. Quality Assurance

Quality control should include identification and assay of all three active ingredients, content uniformity where applicable, dissolution, related substances, microbial and stability requirements as specified in the approved product dossier. Analytical methods must be validated for this combination.

Do not publish universal assay limits or a specific dissolution percentage without the applicable approved finished-product specification. Certificates of analysis can be requested for individual batches, subject to availability.

5. Pharmacology and Clinical Use

Paracetamol: provides analgesic and antipyretic effects. Diclofenac Sodium: is an NSAID that inhibits prostaglandin synthesis and can reduce pain and inflammation. Caffeine: can act as an analgesic adjuvant in some combinations; the clinical benefit of this exact three-ingredient formulation should not be assumed without supporting evidence.

Potential uses may involve short-term painful conditions only where the combination is approved. Claims of guaranteed migraine abortion, superior potency, or a 40% efficacy increase have not been established for this specific product.

6. Export and Regulatory Support

For contract manufacturing or export enquiries, request the current manufacturing license, product permission, market-specific dossier, stability package, artwork, and batch documentation. CTD/ACTD dossiers, COA, COPP, FSC, WHO-GMP evidence, and shipping terms are subject to verification and availability; their inclusion here does not certify that they have been issued.

Product registration and supply are subject to destination-country regulations.

7. Frequently Asked Questions

8. Dosage and Administration

Use only according to the locally approved prescribing information and advice of a qualified healthcare professional. A fixed adult schedule or maximum number of tablets cannot be established from the supplied marketing description alone. The lowest effective NSAID dose for the shortest appropriate duration is generally preferred.

Check for duplicate paracetamol exposure from cold/flu medicines and other painkillers. If the approved label specifies swallowing whole or administration with food, follow that label.

9. Side Effects and Precautions

• Gastrointestinal: Diclofenac can cause serious stomach or intestinal bleeding, ulceration and perforation, sometimes without warning.
• Cardiovascular: NSAIDs can increase the risk of heart attack or stroke, particularly with higher doses or prolonged use.
• Renal: NSAIDs may worsen kidney function, particularly in vulnerable patients.
• Hepatic: Paracetamol overdose can cause severe liver injury; diclofenac may also affect the liver.
• Caffeine: May cause insomnia, palpitations, restlessness and contribute to medication-overuse headaches with frequent analgesic use.
• Pregnancy: NSAIDs should generally be avoided from around 20 weeks of pregnancy unless specifically advised by a clinician and are contraindicated later in pregnancy in many jurisdictions.
• Contraindications/interactions: Consider prior NSAID hypersensitivity, active ulcer/bleeding, severe cardiovascular disease, anticoagulants, other NSAIDs and relevant liver or kidney disease.

Seek urgent medical attention for vomiting blood, black stools, chest pain, breathing difficulty, severe allergic reactions or suspected paracetamol overdose.

10. Storage Instructions

Store according to the approved product label, protected from excessive moisture and light where specified. The proposed below-25°C condition must be verified against stability data for the actual formulation and market. Keep out of reach of children.