Dextromethorphan + Chlorpheniramine Maleate Syrup

Dextromethorphan + CPM 4mg Syrup belongs to the Syrups category within the Cough & Cold and Respiratory therapeutic segments. Unlike the three-active Dextromethorphan + Phenylephrine + CPM combination which addresses congestion alongside cough, this two-active formulation is clinically focused on cough suppression and antihistamine relief — the combination of choice when nasal congestion is not the primary complaint.

The product’s clinical identity is defined by two specific ingredient choices:

• Dextromethorphan HBr 10mg per 5ml — the standard adult antitussive strength, widely prescribed for dry cough in viral upper respiratory illness, post-viral irritative cough, and cold-associated non-productive cough.
• Chlorpheniramine Maleate 4mg per 5ml — double the 2mg CPM level used in most standard cough-cold syrups. This higher antihistamine dose provides stronger suppression of histamine-driven rhinorrhea, sneezing, and allergy-triggered cough — making the formulation relevant where allergic rhinitis, seasonal allergy, or urticaria are contributing to the cough presentation.

For pharmaceutical marketing companies, this is a clean, differentiated SKU in the cough-cold category — the elevated CPM strength creates a distinct prescriber positioning over commodity DMR+CPM 2mg syrups, without the complexity of a three-active formula. Saar Biotech manufactures it from our facility in Baddi with precise two-API assay control, metallic label capability, dome-shape bottle options, and 60ml/100ml pack formats.

Manufacturing Dextromethorphan + CPM 4mg Syrup correctly requires precise two-active assay validation, careful flavour engineering to mask the elevated 4mg CPM bitterness, and packaging flexibility for a syrup category that competes heavily on shelf visual impact.

• Elevated CPM 4mg Taste Engineering: Chlorpheniramine Maleate at 4mg per 5ml — twice the standard dose — produces a significantly more prominent bitter note than 2mg CPM formulations. Saar Biotech’s flavour system is calibrated to mask this elevated bitterness while maintaining the clean cough syrup taste profile that adult patients expect. Getting this right is what separates a brand with strong repeat prescription behavior from one with patient complaints.

• Precise Two-API HPLC Assay: Both Dextromethorphan HBr and Chlorpheniramine Maleate are assayed simultaneously by validated HPLC methodology on every batch. With CPM at 4mg per 5ml, even a small assay deviation represents a proportionally larger active content error than at 2mg — making validated analytical rigor particularly important for this formulation.

• Premium Visual Differentiation — Metallic Labels & Dome Bottles: In the cough syrup segment, packaging visual impact directly influences prescription pull-through and distributor interest. Saar Biotech supports full-size metallic sticker labels, silver leafing, gold leafing, velvet matte finish labels, silver-logo printed caps, and dome-shape 100ml bottles — giving B2B partners the tools to create visually standout cough brands in a crowded shelf environment.

• Flexible 60ml + 100ml Format Support: The 60ml sleeve pack amber bottle suits an economy or sample-size market entry. The 100ml with and without-carton options cover mainstream and premium channel distribution. Shipper configurations from 144×100ml to 300×60ml support distributors across different volume requirements.

Dextromethorphan + CPM 4mg Syrup is manufactured and supplied by Saar Biotech for the following clinical indications where the antitussive + high-antihistamine combination is pharmacologically appropriate:

• Allergy-Driven Dry Cough: When chronic or recurrent dry cough is triggered or maintained by allergic rhinitis, postnasal drip, or urticarial inflammation — the higher CPM 4mg dose provides more complete histamine suppression, reducing the allergic trigger driving the cough reflex.

• Dry Cough with Prominent Rhinorrhea & Sneezing: Presentations where dry cough coexists with profuse runny nose and excessive sneezing — and where nasal congestion is not the dominant complaint — are where this two-active formula has a clinical advantage over three-active products that include Phenylephrine.

• Seasonal Allergy Cough: Seasonal allergic rhinitis-associated dry cough is a frequent prescription trigger. The DMR 10mg + CPM 4mg combination provides both cough reflex suppression and strong antihistamine coverage in one product.

• Nighttime Cough Relief: The higher CPM sedation profile at 4mg per 5ml can be clinically useful when cough is predominantly disturbing nighttime sleep — the antihistamine’s sedating effect complements the antitussive action for more restful overnight symptom control.

Schedule H — Requires valid medical prescription. Not recommended for children under physician supervision or if operating machinery.

Dual-Component Clinical Action

Dextromethorphan Hydrobromide is a centrally acting antitussive derived from levorphanol. Unlike opioid derivatives, it does not act on mu-opioid receptors. Authoritative pharmacological data confirms its primary mechanism involves uncompetitive antagonism at the N-methyl-D-aspartate (NMDA) receptor and high-affinity agonism at the Sigma-1 receptor within the medullary cough center. At 10mg per 5ml, this central action elevates the threshold for coughing, effectively suppressing the cough reflex without depressing ciliary activity or respiratory drive.

Chlorpheniramine Maleate is an alkylamine, first-generation histamine H1 receptor antagonist. It works by competitively and reversibly binding to H1 receptors on respiratory smooth muscle and capillary endothelial cells. This blockade prevents histamine-induced vasodilation, reduces capillary permeability (stopping rhinorrhea), and suppresses the sensory nerve stimulation that causes sneezing. At an elevated dose of 4mg per 5ml, its ability to cross the blood-brain barrier produces a stronger, more pronounced sedative effect than standard 2mg formulations, making it clinically beneficial for nighttime cough suppression.

Manufacturing Integrity

• pH Stability for Both Actives: Dextromethorphan and Chlorpheniramine Maleate have different stability profiles in aqueous syrup systems. Saar Biotech’s formulation team selects a pH, preservative, and vehicle system that maintains both actives stably across the 24-month shelf life.

• Bitterness Masking at Double CPM Dose: The 4mg CPM load requires a more robust flavour and sweetener approach than the standard 2mg CPM formulation. Our flavour system is developed specifically against this elevated active combination to ensure the finished syrup is palatable and commercially acceptable for adult repeat-use.

• Clear Clinical Positioning vs. Standard 2mg CPM Syrups: The 4mg CPM strength is the product’s primary differentiator. It allows pharma marketing companies to position this syrup as a “stronger antihistamine cough relief” product versus standard 2mg CPM formulations — a straightforward, evidence-aligned message that field representatives can communicate clearly to prescribers.

• Nighttime Cough Brand Opportunity: The higher sedation profile of 4mg CPM creates a natural fit for a “nighttime cough relief” brand positioning — a well-established and high-value niche in the cough-cold category that differentiates from daytime multi-symptom products.

• Metallic Label + Dome Bottle = Premium Shelf Identity: The combination of a dome-shape 100ml bottle with a metallic sticker label and a silver-logo printed cap creates a distinctly premium visual identity at negligible additional manufacturing cost.

• 60ml + 100ml Dual-Format Coverage: A 60ml sleeve-pack or without-carton economy format covers price-sensitive pharmacy channels, while a 100ml metallic label with carton format covers branded prescription channels.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Dextromethorphan 10mg + CPM 4mg Syrup from our oral liquid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Dedicated oral liquid filling and capping lines for cough syrups in 60ml and 100ml presentations; supports dome-shape bottles and sleeve pack assembly.
• Capacity: Scalable batch sizes; shipper configurations: 144×100ml, 150×100ml, 160×60ml, 300×60ml available for distributor-level dispatch planning.
• Quality Lab: In-house GLP-certified lab with validated HPLC assay for Dextromethorphan HBr and Chlorpheniramine Maleate, plus pH, specific gravity, MLT, fill volume, and packaging checks.
• Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
• Packaging: 60ml and 100ml bottles; sticker label, full-size metallic sticker, silver leafing, gold leafing, velvet matte finish label, measuring cap, plain cap, printed cap, blue cap, silver-logo printed cap, dome-shape bottle (100ml), sleeve pack (60ml amber), with-carton or without-carton supply.
• MOQ: Starting at 5,000–10,000 units per SKU; case minimum of 150 units per dispatch on select without-carton 100ml SKUs.

1. Warehouse Storage: Store sealed bottles below 30°C in a cool, dry place. High ambient temperatures can accelerate flavour degradation, particularly where 4mg CPM bitterness breakthrough is a risk if the flavour system is weakened by heat exposure.
2. Light & Closure Protection: Keep bottles away from direct sunlight and tightly closed after use.
3. Measuring Cap Use: A calibrated measuring cap ensures accurate 5ml dosing. In an adult cough syrup with a higher CPM dose, accurate dosing also matters for sedation management.
4. Premium Pack Handling: Metallic labels, silver leafing, and dome-shape bottles require careful pack handling to avoid scuffing and denting during transport.

Every commercial batch of Dextromethorphan 10mg + CPM 4mg Syrup is quarantined and released only after a full analytical protocol:

• Two-API HPLC Assay: Simultaneous quantification of Dextromethorphan HBr 10mg and Chlorpheniramine Maleate 4mg per 5ml is performed via validated High-Performance Liquid Chromatography against Indian Pharmacopoeia (IP) standards.
• pH & Specific Gravity: Monitored to ensure syrup stability and correct viscosity.
• Appearance, Colour & Flavour: Batch-to-batch sensory consistency is verified.
• Microbial Limit Testing (MLT): Oral liquid MLT to IP standards.
• Fill Volume & Packaging Inspection: Fill accuracy, cap torque, metallic label finish, measuring-cap inclusion, dome-shape bottle integrity, and batch coding are verified before dispatch.
• Certificate of Analysis (COA): Issued with every B2B consignment.

• Pronounced CNS Depression (CPM 4mg): The 4mg CPM dose produces significant sedation, somnolence, and potential anticholinergic effects. Patients must be warned against driving, operating heavy machinery, or co-administering alcohol, benzodiazepines, or other CNS depressants.
• Critical Pharmacodynamic Interactions (Serotonin Syndrome): Dextromethorphan is strictly contraindicated with Monoamine Oxidase Inhibitors (MAOIs). Co-administration can trigger life-threatening serotonin syndrome. A strict 14-day washout period is required after discontinuing MAOIs. Caution is also advised with SSRIs.
• Contraindications: Known hypersensitivity, narrow-angle glaucoma, symptomatic prostatic hypertrophy, and acute asthma exacerbations.
• Pediatric & Geriatric Precautions: Not recommended for young children under CDSCO guidelines without specific weight-based physician direction. Elderly patients are particularly susceptible to the enhanced anticholinergic and sedative effects of the 4mg CPM dose.

For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Dextromethorphan HBr + Chlorpheniramine Maleate Syrup, please use the B2B enquiry form below.