Dicyclomine + Paracetamol Suspension

Dicyclomine + Paracetamol Suspension belongs to the Suspensions category within the Gastroenterology and Analgesics & Pain Relief therapeutic segments. This combination addresses both the spastic and painful components of gastrointestinal disorders.

Dicyclomine Hydrochloride is a synthetic tertiary amine anticholinergic that blocks muscarinic receptors in the smooth muscle of the stomach and intestine, relieving muscle spasm and cramping. It inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Paracetamol inhibits prostaglandin synthesis, reducing pain and inflammation.

For pharmaceutical marketing companies, this is a high-prescription pediatric and gastroenterology product with consistent demand across IBS, colic, and dysmenorrhea management. Saar Biotech manufactures it from our manufacturing facility in Baddi with validated two-API suspension quality control.

At Saar Biotech, we manufacture Dicyclomine + Paracetamol Suspension using a controlled oral suspension manufacturing process that ensures dose uniformity, palatability, and packaging reliability.

• Two-API Suspension Uniformity: Both Dicyclomine and Paracetamol must be uniformly distributed to ensure consistent dosing. Our high-shear mixing and validated fill procedures ensure every 5ml dose delivers the full label claim.
• Pediatric Taste Masking: Both APIs have bitter profiles. We develop palatable suspension bases that effectively mask bitterness, ensuring children accept each dose without resistance.
• pH and Stability Management: Both actives must remain chemically stable for 24 months under tropical storage conditions. Our formulation team selects preservatives, pH buffers, and suspending agents that protect both actives from degradation.
• 60ml Pack Coverage: From dark amber bottles to drip-off embossed cartons and company-logo printed caps — our packaging options help gastroenterology brands stand out at pharmacy level.

Dicyclomine + Paracetamol Suspension is manufactured and supplied by Saar Biotech for the following established clinical indications:

• Irritable Bowel Syndrome (IBS) : Relief from abdominal pain, cramps, and discomfort
• Biliary Colic: Relief from pain associated with biliary tract spasm
• Intestinal Colic: Relief from intestinal spasm and pain
• Renal Colic: Relief from pain associated with urinary tract spasm
• Spasmodic Dysmenorrhea: Relief from painful menstrual cramps
• Common Cold & Flu: Symptomatic relief from body ache and muscle pain

Schedule H — Requires valid medical prescription. Use in children only under physician supervision.

Clinical Mechanism of Action

Dicyclomine Hydrochloride is a synthetic tertiary amine anticholinergic. It relieves smooth muscle spasm of the gastrointestinal tract via a dual mechanism: (1) a specific anticholinergic effect (antimuscarinic) at acetylcholine receptor sites, and (2) a direct action on smooth muscle. It inhibits gastrointestinal propulsive motility, decreases gastric acid secretion, and controls excessive tracheal, pharyngeal, and bronchial secretions.

Paracetamol (Acetaminophen) is a non-steroidal anti-inflammatory drug belonging to the analgesic class. It inhibits prostaglandin synthesis, reducing pain and inflammation. It is used to relieve mild to moderate pain and fever.

Manufacturing Integrity

• Two-API Suspension Uniformity: Both actives must be uniformly distributed. Our suspending agent system ensures consistent dispersion of both Dicyclomine and Paracetamol.
• pH and Stability Management: The suspension vehicle is pH-buffered to maintain both actives’ chemical stability for 24 months.
• Taste Masking: Our flavour systems are engineered to mask the bitter profiles of both APIs, ensuring pediatric compliance.

• Rapid Absorption: Dicyclomine is rapidly absorbed from the GI tract, attaining peak plasma concentration in 1 hour. Paracetamol is readily absorbed, achieving peak concentration in 30–60 minutes.
• Extended Duration: Dicyclomine has a half-life of approximately 5 hours; Paracetamol has a half-life of approximately 2 hours.
• Broad Prescriber Base: Used across gastroenterology, pediatrics, and general medicine — wide prescriber reach.
• 60ml Pack Logic: The 60ml format provides a convenient supply for pediatric and short-course adult treatment.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Dicyclomine + Paracetamol Suspension from our dedicated oral suspension manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Oral suspension manufacturing area with controlled processing, automated bottle filling, capping, labelling, and carton packing lines suited for 60ml presentations.
• Capacity: Scalable from brand-entry launches to large commercial batches; 160×60ml distributor dispatch configurations available.
• Quality Lab: In-house GLP-certified lab with validated HPLC assay for both actives, plus pH, viscosity, suspension uniformity, MLT, and fill volume checks.
• 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, drip-off carton, measuring cup, printed cap, with-carton or without-carton supply.
• MOQ: Starting at 5,000–10,000 units per SKU.

1. Warehouse Conditions: Store below 30°C in a cool, dry environment. Do not freeze.
2. Shake Well Before Every Dose: Critical for uniform API distribution, ensuring every 5ml dose delivers the full label claim.
3. Measuring Cup Use: A calibrated measuring cup ensures accurate dosing, particularly important for pediatric weight-based administration.
4. Light Protection: Dark amber bottles and outer cartons protect the suspension from light-induced degradation.

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

• Two-API HPLC Assay: Simultaneous quantification of Dicyclomine Hydrochloride 5mg and Paracetamol 125mg per 5ml against IP specifications.
• Suspension Uniformity & Re-Dispersibility: Sediment behaviour and post-shaking uniformity are evaluated to ensure dose-to-dose consistency.
• pH & Viscosity Testing: The suspension’s pH and flow characteristics are monitored to maintain stability.
• Microbial Limit Testing (MLT): IP-compliant microbiological testing confirming absence of specified pathogens.
• Certificate of Analysis (COA): Issued with every B2B batch.

• Anticholinergic Effects: Dicyclomine may cause drowsiness, blurred vision, dry mouth, and constipation. Patients should avoid driving and operating machinery.
• Hepatotoxicity Risk: Paracetamol overdose can cause severe hepatic necrosis. Strict adherence to weight-based dosing is mandatory.
• Contraindications: Known hypersensitivity to either component; glaucoma, prostatic hypertrophy, myasthenia gravis; severe hepatic impairment.
• Drug Interactions: Avoid alcohol, MAO inhibitors, and other CNS depressants. Antacids may decrease GI absorption of Dicyclomine.

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