Pantoprazole Sodium Delayed Release Tablets USP 20mg Technical Specification:
Product Name: | Pantoprazole Sodium Delayed Release Tablets USP 20mg |
Brand Name: | Pantopap |
Strength: | 20mg, 40mg |
Dosage Form: | Tablets (Delayed Release Enteric Coated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 30s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antacid, Gastroenterological |
Indication: | Pantoprazole reduces the amount of acid your stomach makes. |
Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pantoprazole Sodium Delayed Release Tablets USP 20mg (Pantopap)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Pantoprazole Sodium Delayed Release Tablets USP 20mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 20mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow
THERAPEUTIC INDICATIONS:
Pantoprazole reduces the amount of acid your stomach makes. It’s used for heartburn, acid reflux and gastro-oesophageal reflux disease (GORD) – GORD is when you keep getting acid reflux.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
THERAPEUTIC INDICATIONS:
Pantoprazole reduces the amount of acid your stomach makes. It's used for heartburn, acid reflux and gastro-oesophageal reflux disease (GORD) – GORD is when you keep getting acid reflux.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.