WHO-GMP Certified Commercial Pack · Product Code: AKP-086
Dicyclomine Hydrochloride 10mg & Activated Dimethicone 40mg Drops (per ml)
Formulation Overview: Antispasmodic and antiflatulent paediatric oral drops combining direct anticholinergic bowel-spasm relaxation with surface-active gas bubble coalescence. Formulated with Dicyclomine Hydrochloride IP 10 mg + Activated Dimethicone (Simethicone) IP 40 mg (per ml) (10 mg + 40 mg / ml) in Paediatric Anti-Colic Oral Drops dosage form under Gastroenterology & PPIs, manufactured to IP / BP / USP Compendial standards and supplied in 10 ml / 15 ml Amber PET Bottle with Graduated Dropper Pipette with complete eCTD/ACTD regulatory dossiers, Zone IVb stability, and batch CoA for African NRAs (NAFDAC, PPB, SAHPRA, TMDA, FDA Ghana) and global tenders.
| Item Code (SKU) | AKP-086 |
|---|---|
| Therapeutic Sector | Gastroenterology & PPIs |
| Dosage Form | Paediatric Anti-Colic Oral Drops |
| Active Ingredient | Dicyclomine Hydrochloride IP 10 mg + Activated Dimethicone (Simethicone) IP 40 mg (per ml) |
| Strength / Purity | 10 mg + 40 mg / ml |
| Clinical Indication | Infantile smooth-muscle intestinal colic, abdominal griping pain, and trapped gas flatulence (>6 months) |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 ml / 15 ml Amber PET Bottle with Graduated Dropper Pipette |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; shake gently before use |
| Minimum Order Quantity | 1000 Packs |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial Export Ready |