Paracetamol + Promethazine Syrup
Paracetamol IP and Promethazine Hydrochloride IP Oral Syrup · Cough & Cold, Anti-Histamines, Analgesics & Pain Relief
SYRUP PRESENTATION:
Product Profile
Paracetamol + Promethazine Syrup is a clinically established combination formulation for symptomatic relief of cold, fever, and allergic symptoms. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this syrup with validated two-API quality control and precise taste-masking, ensuring reliable therapeutic performance in every 5ml dose.
DCGI Approved
Comprehensive documentation and CDSCO support for rapid market entry in India.
Fast Turnaround
30-45 days lead time for new batches with state-of-the-art logistics.
Pan-India Supply & Contract Manufacturing
Description & Therapeutic Class
Paracetamol + Promethazine Syrup belongs to the Syrups category within the Cough & Cold and Anti-Histamines therapeutic segments. This combination addresses both fever/pain and allergic symptoms in a single formulation.
- Paracetamol 125mg — analgesic and antipyretic for fever and body ache
- Promethazine Hydrochloride 5mg — sedating antihistamine for allergic symptoms
For pharmaceutical marketing companies, this is a high-prescription cold-care product with consistent demand. Saar Biotech manufactures it from our manufacturing facility in Baddi.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture this syrup using a controlled oral syrup manufacturing process that ensures dose uniformity, palatability, and packaging reliability.
- Two-API Uniformity: Both actives are uniformly distributed for consistent dosing.
- Taste Masking: Both APIs have bitter profiles requiring expert taste-masking.
- pH and Stability Management: Both actives remain chemically stable for 24 months.
- 60ml Pack Coverage: From dark amber bottles to drip-off embossed cartons.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Use
This syrup is manufactured and supplied by Saar Biotech for the following established clinical indications:
- Common Cold & Fever: Symptomatic relief of fever, body ache, and malaise
- Allergic Rhinitis: Relief from runny nose, sneezing, and allergic symptoms
- Upper Respiratory Infections: Symptomatic management of cold and flu symptoms
Schedule H — Requires valid medical prescription. Not for use in children under 2 years.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Paracetamol inhibits prostaglandin synthesis in the hypothalamic thermoregulatory centre, reducing fever and raising the pain threshold. Promethazine is a first-generation antihistamine that blocks H1 receptors, reducing histamine-mediated rhinorrhea, sneezing, and allergic symptoms.
Manufacturing Integrity
- Two-API Compatibility: Both actives remain chemically stable in the shared syrup vehicle.
- pH Stability: The syrup base is pH-buffered to maintain both actives’ chemical integrity.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for this syrup from our dedicated oral liquid manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Oral liquid manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines.
- Capacity: Scalable from brand-entry launches to large commercial batches.
- Quality Lab: In-house GLP-certified lab with validated HPLC assay for both actives.
- Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
- Packaging: 60ml PET or dark amber bottles; sticker label, metallic label, measuring cup, printed cap.
- MOQ: Starting at 5,000–10,000 units per SKU.
Pan-India Supply & Contract Manufacturing
Storage & Handling Guidelines
- Warehouse Conditions: Store below 30°C in a cool, dry environment.
- Light Protection: Keep bottles away from direct sunlight.
- Measuring Cap Use: A calibrated measuring cap ensures accurate dosing.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every commercial batch is quarantined until it passes a comprehensive analytical release protocol:
- Two-API HPLC Assay: Simultaneous quantification of Paracetamol and Promethazine.
- pH & Viscosity Testing: The syrup’s pH and flow characteristics are monitored.
- Microbial Limit Testing (MLT): IP-compliant microbiological testing.
- Certificate of Analysis (COA): Issued with every B2B batch.
Pan-India Supply & Contract Manufacturing
Safety Profile & Precautions
- Sedation (Promethazine): Causes significant drowsiness; avoid driving and alcohol.
- Contraindications: Hypersensitivity to any component; epilepsy, glaucoma, prostatic hypertrophy; children under 2 years.
- Drug Interactions: Potentiates CNS depressants, alcohol, and sedatives.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Paracetamol + Promethazine Syrup, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Paracetamol + Promethazine Syrup
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Paracetamol + Promethazine Syrup?
How does this combination work?
What is the standard dosing protocol?
What are the key contraindications and precautions?
What are the common side effects?
B2B Manufacturing Guide for Paracetamol + Promethazine Syrup
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.

