Paracetamol + Phenylephrine + CPM Drops

Paracetamol + Phenylephrine + CPM Drops belong to the Oral Drops category within the Pediatric Care, Cough & Cold, and Anti-Pyretic therapeutic segments. The drops format is clinically preferred for young children because:

• Concentrated dose in minimal volume — 125mg Paracetamol, 2.5mg Phenylephrine, and 1mg CPM per 1ml means only 0.5–1ml is needed per dose, reducing the volume burden for young children.
• Dropper-controlled precision — a calibrated dropper enables true individualized dosing based on the child’s weight.
• Compliance advantage — smaller volume = easier administration, less spillage, and better acceptance.

The three-molecule combination addresses the complete symptom cluster of pediatric cold: Paracetamol for fever and pain, Phenylephrine for nasal decongestion, and Chlorpheniramine Maleate for histamine-driven rhinorrhea and sneezing.

Saar Biotech manufactures these drops from our facility in Baddi with dedicated oral drops filling lines, calibrated dropper assembly, and validated HPLC assay for all three actives at the per-1ml concentration.

Manufacturing pediatric drops correctly requires specific capabilities that differ from standard suspension manufacturing — particularly around dropper calibration, dose uniformity at concentrated levels, and the paediatric flavour tolerance profile.

• Calibrated Dropper Precision: The dropper tip and bulb assembly must deliver a consistent, repeatable volume per squeeze — calibrated specifically for the viscosity of this drops base. Saar Biotech uses pharma-grade calibrated dropper systems verified for ±5% volume accuracy.

• Concentrated Active Uniformity: At 125mg Paracetamol, 2.5mg Phenylephrine, and 1mg CPM per 1ml, any non-uniformity creates much larger dose errors per drop. Our quality protocols include uniformity-of-dose checks across the fill volume.

• Paediatric Flavour Development: Drops are administered undiluted and directly into the child’s mouth. The concentrated flavour experience must be carefully calibrated — sweet enough to mask Chlorpheniramine’s bitterness and Phenylephrine’s astringency, but not overpowering.

• Premium 15ml Dropper Pack Execution: The 15ml amber PET bottle with calibrated dropper, drip-off brand embossed carton, and printed cap gives B2B pharma brands a visually professional paediatric drops pack.

Paracetamol + Phenylephrine + CPM Drops are manufactured and supplied by Saar Biotech for the following established clinical indications in pediatric cold and fever management:

• Fever in Children: Paracetamol 125mg per 1ml enables accurate weight-based fever management. The antipyretic effect is predictable, reliable, and free of gastric irritation.

• Nasal Congestion in Children: Phenylephrine 2.5mg per 1ml provides targeted nasal mucosal vasoconstriction at doses calibrated for the pediatric weight range.

• Runny Nose & Sneezing: Chlorpheniramine Maleate 1mg per 1ml addresses the histamine-driven component of cold symptoms — rhinorrhea, sneezing, and watery discharge.

• Multi-Symptom Cold Management: Combining all three components in a calibrated drops format reduces the number of separate medicines a parent must administer.

Schedule H — Dispensed only on valid medical prescription. Dose must be calculated by body weight and prescribed by a physician.

Triple-Component Clinical Action

Paracetamol acts as a centrally-mediated antipyretic and analgesic. It inhibits prostaglandin synthesis in the hypothalamic thermoregulatory centre, promoting heat dissipation via vasodilation and sweating.

Phenylephrine Hydrochloride is a potent, direct-acting alpha-1 adrenergic receptor agonist. In the nasal mucosa, it stimulates these receptors on vascular smooth muscle, causing rapid vasoconstriction that reduces mucosal oedema and restores nasal airway patency.

Chlorpheniramine Maleate is a first-generation alkylamine antihistamine. It acts as a competitive antagonist at the histamine H1 receptor, preventing histamine from triggering capillary permeability (rhinorrhea) and sensory nerve irritation (sneezing).

Manufacturing Integrity

• Uniform Concentration Across 15ml Fill: Saar Biotech’s uniform mixing, fill process, and dose uniformity QC testing eliminate concentration gradients.
• Dropper Calibration to Base Viscosity: Dropper calibration is performed specifically against the finished product’s viscosity profile.
• Microbial Control: Our preservative system and microbial limit testing protocols ensure the product remains microbiologically safe from first to final dose.

• Rapid Fever Resolution: Paracetamol absorbed from a well-formulated drops base reaches Tmax within 30–60 minutes — giving the prescribing physician and parent a visible, reassuring clinical outcome quickly.

• Drops Segment Premium Pricing: Pediatric oral drops command a price premium over suspension formats. The calibrated dropper, amber PET bottle, and premium carton presentation justify a higher brand MRP.

• 360×15ml Dispatch Configuration: Bulk shipping in 360-unit shippers optimizes logistics cost for distributors handling high-volume seasonal pediatric cold demand.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Paracetamol + Phenylephrine + CPM Oral Drops from our dedicated oral liquid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral drops filling line with amber PET bottle filling, calibrated dropper assembly, carton packing, and dedicated pediatric liquid manufacturing protocols.
• Capacity: Scalable from 5,000-unit brand-entry batches to 2,00,000+ unit commercial runs; 360×15ml shipper configurations.
• Quality Lab: In-house GLP-certified lab with HPLC assay for all three actives per 1ml, uniformity-of-dose testing, pH, viscosity, MLT, and dropper calibration verification.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 15ml amber PET bottle with calibrated dropper; with/without carton, sticker label, drip-off brand embossed carton, printed cap.
• MOQ: Starting at 5,000–10,000 units per SKU.

1. Store Tightly Closed: The dropper bottle must be kept tightly sealed between doses to prevent evaporation and microbial ingress.
2. Temperature & Light Protection: Store below 30°C in a cool, dry place away from direct sunlight.
3. No Freezing: Sub-zero temperatures disrupt the drops base viscosity profile and dropper calibration behaviour.
4. Dropper Hygiene: The dropper tip should not contact the child’s mouth, tongue, or lips during administration.
5. Shake Lightly Before Use: A gentle inversion or light shake before each use ensures uniform flavour and active distribution.

Every commercial batch is quarantined until it passes a comprehensive release protocol:

• Three-Active HPLC Assay: Paracetamol 125mg, Phenylephrine HCl 2.5mg, and CPM 1mg per 1ml confirmed against IP standards.
• Uniformity of Dose: Multiple samples drawn from different fill positions confirm homogeneous active distribution.
• pH & Viscosity Testing: pH monitored for chemical stability; viscosity checked against dropper-calibrated specification.
• Microbial Limit Testing (MLT): IP-compliant testing confirming absence of specified pathogens.
• Dropper Calibration Verification: Dropper assembly verified to deliver labeled volume within acceptable tolerance.
• Certificate of Analysis (COA): Issued with every B2B batch.

• Hepatotoxicity Risk (Paracetamol): Strict adherence to weight-based dosing (maximum 60 mg/kg/day) is mandatory. Concurrent use of other paracetamol-containing products must be avoided.
• CNS Depression (CPM): Chlorpheniramine produces sedation and somnolence. In rare cases, paradoxical CNS excitation may occur.
• Sympathomimetic Precautions (Phenylephrine): May cause mild sympathetic stimulation. Contraindicated in children with severe cardiovascular disease or those receiving MAOIs.
• Regulatory Guidance: Not recommended for children under 2 years without strict physician supervision.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Paracetamol + Phenylephrine + CPM Oral Drops, please use the B2B enquiry form below.