Pantoprazole Sodium Delayed Release Tablets USP 40mg Technical Specification:

Product Name:Pantoprazole Sodium Delayed Release Tablets USP 40mg
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 40mg (Pantopap)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Pantoprazole Sodium Delayed Release Tablets USP 40mg
    Each enteric coated delayed release tablet contains:
    Pantoprazole Sodium sesquihydrate USP
    Equivalent to Pantoprazole…………… 40mg
    Excipients……………………………………….q.s.
    Color: Brilliant blue FCF

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:

A) Pantoprazole Sodium Delayed Release Tablets USP 20mg (Pantopap)
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg (Pantopap)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) 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

B) Pantoprazole Sodium Delayed Release Tablets USP 40mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 40mg
Excipients……………………………………….q.s.
Color: Brilliant blue FCF


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.