Esomeprazole Magnesium Delayed Release Capsules 20mg (Prosium)
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Esomeprazole Magnesium Delayed Release Capsules 20mg Technical Specification:

Product Name:Esomeprazole Magnesium Delayed Release Capsules 20mg
Brand Name:Prosium
Strength:20mg, 40mg
Dosage Form:Capsules (delayed Release)
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:Anti-Ulcer, Antacid, Gastroenterological
Indication: Esomeprazole is used to treat conditions where there is too much acid in the stomach.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Esomeprazole Magnesium Delayed Release Capsules 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Esomeprazole Magnesium Delayed Release Capsules 20mg
    Each delayed Release capsule contains:
    Esomeprazole Magnesium USP
    Equivalent to Esomeprazole ……………….20mg
    (As delayed release pellets)
    Excipients………………………………………………q.s.
    Approved colours used in hard gelatin capsule shells.

THERAPEUTIC INDICATIONS:

Esomeprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid related indigestion and heartburn.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Stronger, longer acid control the most powerful acid blocker available.

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

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) Esomeprazole Magnesium Delayed Release Capsules 20mg
B) Esomeprazole Magnesium Delayed Release Capsules 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Esomeprazole Magnesium Delayed Release Capsules 20mg
Each delayed Release capsule contains:
Esomeprazole Magnesium USP
Equivalent to Esomeprazole ……………….20mg
(As delayed release pellets)
Excipients……………………………………………...q.s.
Approved colours used in hard gelatin capsule shells.

B) Esomeprazole Magnesium Delayed Release Capsules 40mg
Each delayed Release capsule contains:
Esomeprazole Magnesium USP
Equivalent to Esomeprazole ……………….40mg
(As delayed release pellets)
Excipients……………………………………………. q.s.
Approved colours used in hard gelatin capsule shells.

THERAPEUTIC INDICATIONS:

Esomeprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid related indigestion and heartburn.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Stronger, longer acid control the most powerful acid blocker available.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

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.