GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Enteric Coated Pantoprazole Sodium & Domperidone SR Capsule
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Enteric Coated Pantoprazole Sodium & Domperidone SR Capsule
Each hard gelatin capsule contains:
Pantoprazole Sodium IP
Equivalent to Pantoprazole………..40mg
(In the form of two gastro resistant tablet)
Domperidone IP………………………..30mg
(As Sustained Release Pellets)
Excipients…………………………………..q.s
Colours: Titanium Dioxide IP, Ferric Oxide
NF Red & Ferric Oxide NF Yellow
Approved Colour used for capsule shell.
Each hard gelatin capsule contains:
Pantoprazole Sodium IP
Equivalent to Pantoprazole………..40mg
(In the form of two gastro resistant tablet)
Domperidone IP………………………..30mg
(As Sustained Release Pellets)
Excipients…………………………………..q.s
Colours: Titanium Dioxide IP, Ferric Oxide
NF Red & Ferric Oxide NF Yellow
Approved Colour used for capsule shell.
THERAPEUTIC INDICATIONS:
OMPERIDONE+PANTOPRAZOLE is a widely used medicine to treat peptic ulcers and gastroesophageal reflux disease (GERD). It also prevents the release of stomach acid and relieves symptoms of food pipe lining inflammation (esophagitis), and gastroesophageal reflux disease (GERD), or heartburn.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Capsule to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Capsule to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.
Enteric Coated Pantoprazole Sodium & Domperidone SR Capsules (40mg+30mg) Technical Specification:
| Product Name: | Enteric Coated Pantoprazole Sodium & Domperidone SR Capsule |
| Brand Name: | PANTOTAJ-DSR |
| Strength: | 40mg+30mg |
| Dosage Form: | Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 capsule each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Gastroenterological |
| Indication: | OMPERIDONE+PANTOPRAZOLE is a widely used medicine to treat peptic ulcers and gastroesophageal reflux disease (GERD). It also prevents the release of stomach acid and relieves symptoms of food pipe lining inflammation (esophagitis), and gastroesophageal reflux disease (GERD), or heartburn. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Enteric Coated Pantoprazole Sodium & Domperidone SR Capsule
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Enteric Coated Pantoprazole Sodium & Domperidone SR Capsule
Each hard gelatin capsule contains:
Pantoprazole Sodium IP
Equivalent to Pantoprazole………..40mg
(In the form of two gastro resistant tablet)
Domperidone IP………………………..30mg
(As Sustained Release Pellets)
Excipients…………………………………..q.s
Colours: Titanium Dioxide IP, Ferric Oxide
NF Red & Ferric Oxide NF Yellow
Approved Colour used for capsule shell.
THERAPEUTIC INDICATIONS:
OMPERIDONE+PANTOPRAZOLE is a widely used medicine to treat peptic ulcers and gastroesophageal reflux disease (GERD). It also prevents the release of stomach acid and relieves symptoms of food pipe lining inflammation (esophagitis), and gastroesophageal reflux disease (GERD), or heartburn.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Capsule to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.
