Dextromethorphan + Phenylephrine + CPM Syrup
Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup · Cough & Cold, Respiratory
Dextromethorphan 5mg + Phenylephrine 5mg + CPM 2mg
Dextromethorphan 10mg + Phenylephrine 5mg + CPM 2mg
Dextromethorphan 15mg + Phenylephrine 5mg + CPM 2mg
Product Profile
Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride + Chlorpheniramine Maleate Syrup is a triple-action, non-narcotic cough and cold formulation — delivering dry cough suppression, nasal decongestion, and antihistamine relief in one convenient oral liquid for adult and family cold-care portfolios. As a WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures this Dextromethorphan 15mg + Phenylephrine 5mg + CPM 2mg Syrup with precise three-API quality control, sugar-free variant capability, and flexible 100ml packaging for third-party manufacturing, contract manufacturing, and private-label brand supply across India.
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
Dextromethorphan 15mg + Phenylephrine + CPM Syrup belongs to the Syrups category within the Cough & Cold and Respiratory therapeutic segments — one of the highest-volume and most seasonally dynamic categories in Indian pharmaceutical retail and prescription markets.
What distinguishes this formulation from the common 10 mg DMR cough syrup market is the higher 15 mg Dextromethorphan strength per 5 ml, which provides a more robust antitussive effect for adult patients with moderate dry cough. The three-molecule architecture addresses the complete upper respiratory symptom cluster:
- Dextromethorphan HBr 15mg — centrally acting non-opioid antitussive for dry cough suppression
- Phenylephrine HCl 5mg — alpha-adrenergic nasal decongestant for blocked nasal passages
- Chlorpheniramine Maleate 2mg — first-generation H1 antihistamine for sneezing, watery eyes, and rhinorrhea
This combination is a straightforward yet commercially strong product for pharma marketing companies building cough-cold Syrup portfolios. Saar Biotech manufactures it from our facility in Baddi with validated three-API assay controls, sugar-free cherry/strawberry formulation capability, and 100 ml pack formats designed for seasonal high-volume distribution.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Dextromethorphan 15mg + Phenylephrine + CPM Syrup using a controlled oral liquid manufacturing process focused on three-API assay accuracy, clean taste profile, and packaging flexibility for both standard and premium cough-cold brand launches.
15mg DMR Strength — Clear Product Differentiation: The elevated 15 mg Dextromethorphan dose gives B2B partners a distinct dry cough positioning advantage over the crowded 10 mg syrup segment. Field teams can communicate this higher-strength differentiation clearly to prescribers and pharmacists without complex clinical claims.
Sugar-Free Cherry & Strawberry Capability: Sugar-free variants in cherry and strawberry flavours are available for adult-focused brands, diabetic-conscious consumers, and premium urban positioning. Our formulation team selects sweetener and flavour systems that maintain the expected cough syrup texture and taste experience without a sucrose base.
Three-API Uniformity & Assay Control: Combining a central antitussive, a sympathomimetic decongestant, and a sedating antihistamine in one liquid base requires validated assay procedures for all three molecules simultaneously. Our GLP-certified laboratory performs HPLC confirmation of all three actives on every batch before release.
Versatile Pack Format Support: From 15 ml travel packs and 60 ml entry packs to 100 ml standard and 120 ml high-volume formats — with metallic labels, leafing, shrink-packs, measuring caps, and logo-printed caps — Saar Biotech offers the packaging range to cover economy, standard, and premium cough syrup SKUs.
This combination of strength-led differentiation and packaging versatility helps your DMR 15mg + Phenylephrine + CPM brand compete effectively during peak cough-cold demand cycles.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Use
Dextromethorphan 15mg + Phenylephrine + CPM Syrup is manufactured and supplied by Saar Biotech for the following established clinical indications in adult and pediatric-under-supervision upper respiratory management:
Dry, Non-Productive Cough: The primary indication. Dextromethorphan 15mg centrally elevates the cough threshold, suppressing irritating dry cough without mucus clearance interference. Not suitable for productive cough requiring expectoration.
Nasal Congestion & Sinus Blockage: Phenylephrine constricts dilated nasal blood vessels, reducing mucosal swelling and improving nasal airflow. Useful for blocked nose and sinus pressure accompanying cold or allergic rhinitis.
Runny Nose, Sneezing & Watery Eyes: Chlorpheniramine Maleate blocks H1 histamine receptors, reducing rhinorrhea, sneezing, postnasal drip, and allergic eye symptoms — the hallmark symptoms of cold overlapping with allergic rhinitis.
Multi-Symptom Cold & Allergy Relief: The three-molecule formula provides combined coverage for the most common cold presentation: dry cough + blocked nose + runny nose + sneezing, making it a complete cold-care SKU for prescriber convenience.
Schedule H — Requires a valid medical prescription. Patients with persistent fever, breathing difficulty, or symptoms worsening after 3 days should be referred for medical evaluation.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Triple-Action Clinical Mechanism
Dextromethorphan Hydrobromide is a non-opioid, non-addictive antitussive that acts on sigma-1 receptors and inhibits NMDA receptors in the brainstem cough center. At 15 mg per 5 ml, it elevates the cough threshold, reducing the frequency and intensity of dry, irritating cough without affecting respiratory mucus clearance mechanisms. Unlike opioid antitussives, it carries no dependency risk at therapeutic doses.
Phenylephrine Hydrochloride is a selective alpha-1 adrenergic agonist. When administered orally, it causes vasoconstriction in the nasal mucosal blood vessels, reducing mucosal engorgement and edema responsible for nasal obstruction. Its oral bioavailability requires careful dose selection, and the 5 mg per 5 ml level is the standard therapeutic dose for oral nasal decongestant use in India.
Chlorpheniramine Maleate competitively antagonizes histamine at H1 receptors, blocking histamine-induced vascular permeability, glandular secretion (rhinorrhea), smooth muscle contraction, and sensory nerve stimulation (itching, sneezing). Its CNS penetration produces the characteristic sedation that must be managed through patient counseling.
Manufacturing Integrity
Three-API pH and Compatibility Stability: Dextromethorphan, Phenylephrine, and Chlorpheniramine have different chemical stability profiles in aqueous solution. Saar Biotech’s formulation team selects a vehicle pH and preservative system that maintains all three actives stably throughout the 24-month shelf life — preventing degradation of any single molecule from reducing the product’s full triple-action efficacy.
Taste & Colour Uniformity: Dextromethorphan and Phenylephrine can contribute bitter or medicinal notes. Our flavour system — in standard mixed-fruit, cherry (sugar-free), and strawberry (sugar-free) directions — masks these notes effectively, maintaining batch-to-batch sensory consistency across the 100 ml commercial pack.
Pan-India Supply & Contract Manufacturing
Pharmacokinetics & B2B Commercial Value
Rapid Onset of Cough Suppression: Dextromethorphan is well absorbed orally and achieves peak plasma concentration within 2–3 hours. The cough-suppressant effect is noticeable within the first dose cycle, giving patients and prescribers a clear, observable clinical outcome — important for brand trial conversion and repeat prescription behavior.
Phenylephrine Nasal Effect Duration: Oral Phenylephrine provides up to 4 hours of nasal decongestant activity per dose. This supports a standard three-to-four-times-daily dosing regimen that aligns conveniently with the 100 ml pack volume and typical 5–7 day cold treatment course.
Sugar-Free Premium Market Access: The sugar-free cherry and strawberry variants enable pharmaceutical marketing companies to enter the growing adult cough syrup segment where sugar-free labeling is increasingly demanded by diabetic patients, fitness-conscious consumers, and urban pharmacies. This is a differentiation angle that many generic 10 mg DMR syrups cannot match.
Pack Versatility Across Price Tiers: The 15 ml sample pack supports brand trial by medical representatives. The 60 ml and 100 ml formats capture the mainstream prescription market. The 120 ml pack and shrink-configured dispatch serve bulk or wholesale channels. Together, these give B2B partners complete market coverage without separate formulation development.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Dextromethorphan 15mg + Phenylephrine + CPM Syrup from our dedicated cough-cold syrup manufacturing area in Baddi, Himachal Pradesh.
- Facility: Oral liquid filling lines suitable for cough syrups in 15 ml, 60 ml, 100 ml, and 120 ml presentations with automated filling, capping, labeling, and carton packing.
- Capacity: Supporting pilot brand launches and high-volume seasonal runs; 100×100 ml shrink pack configurations available for distributor-level bulk supply.
- Quality Lab: In-house GLP-certified lab with validated HPLC assay for all three actives — Dextromethorphan, Phenylephrine, and Chlorpheniramine Maleate — plus pH, viscosity, MLT, and fill volume checks.
- Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
- Packaging: Standard label, metallic sticker, silver/gold leafing, sleeve pack, drip-off label, measuring cap, tricolour measuring cap, logo-printed PP cap, WHO-GMP style cap, shrink-pack, with-carton or without-carton.
- MOQ: Starting at 5,000–10,000 units per SKU; advance seasonal booking recommended for peak cough-cold demand periods.
Pan-India Supply & Contract Manufacturing
Storage & Handling Guidelines
- Warehouse Conditions: Store sealed bottles below 30°C in a cool, dry place. High ambient temperatures can affect flavour stability and syrup clarity — especially for sugar-free cherry and strawberry variants with sensitive sweetener systems.
- Light Protection: Keep bottles away from direct sunlight. Amber or suitably coloured pharmaceutical bottles with outer cartons provide adequate light protection during transit and retail display.
- Measuring Cap Use: A calibrated measuring cap ensures the correct 5 ml dose is measured accurately. Household spoons can lead to incorrect dosing, which reduces therapeutic reliability and patient confidence.
- Premium Pack Handling: Metallic labels, leafing, and sleeve packs should be protected from scuffing and moisture during transit — particularly important for brands competing on visual presentation in cough-cold category pharmacy shelves.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every commercial batch of Dextromethorphan 15mg + Phenylephrine + CPM Syrup is subjected to a validated analytical release protocol before dispatch:
- Three-API HPLC Assay: Simultaneous quantification of Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate confirms that each active meets 100% label claim — protecting the brand’s clinical and commercial reliability.
- pH & Specific Gravity: Monitored to ensure the syrup base remains within stability parameters and maintains the correct density and mouthfeel expected for a cough cold syrup.
- Appearance, Colour & Flavour Inspection: Visual and sensory consistency is evaluated batch-to-batch, especially for sugar-free cherry and strawberry variants where colour and flavour are core to patient acceptance.
- Microbial Limit Testing (MLT): IP-compliant microbial quality testing confirms the absence of specified pathogens and adherence to total microbial count limits for oral liquid products.
- Fill Volume & Pack Inspection: Fill accuracy, cap integrity, label placement, measuring-cap inclusion, and shrink-pack quality are inspected before dispatch to ensure zero commercial complaints on receipt.
- Certificate of Analysis (COA): Provided with every B2B batch for partner documentation, regulatory records, and distributor verification.
Pan-India Supply & Contract Manufacturing
Safety Profile & Precautions
- Common Side Effects: Drowsiness, dry mouth, dizziness (CPM), restlessness, anxiety, tremor, elevated blood pressure (Phenylephrine), or mild nausea. Patients should avoid driving and alcohol if sedation occurs.
- Critical Drug Interaction: Dextromethorphan must NOT be combined with MAO inhibitors or used within 14 days of stopping them — risk of serotonin syndrome. SSRIs also require caution. This interaction must be clearly labeled.
- Contraindications: Known hypersensitivity to any component. Avoid in uncontrolled hypertension, severe coronary artery disease, angle-closure glaucoma, urinary retention, and severe hepatic impairment.
- Healthcare professionals should review complete prescribing information before recommending in children, elderly patients, cardiovascular-risk patients, or those on psychiatric, sedative, or sympathomimetic co-medications.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Dextromethorphan 15mg + Phenylephrine + CPM Syrup, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Dextromethorphan + Phenylephrine + CPM Syrup
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What conditions is Dextromethorphan + Phenylephrine + CPM Syrup prescribed for?
What is the clinical difference between the 5mg, 10mg, and 15mg Dextromethorphan strengths?
Is Chlorpheniramine Maleate sedating in this formulation?
Is this syrup appropriate for productive cough with mucus?
What drug interactions should prescribers be aware of with this cough syrup?
B2B Manufacturing Guide for Dextromethorphan + Phenylephrine + CPM Syrup
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
