GENERIC NAME OF THE MEDICINAL PRODUCT

A. Racecadotril Capsules IP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Racecadotril Capsules IP 100mg
Each hard gelatin capsule contains:
Racecadotril IP……………………100mg
Excipients…………………………....q.s
Colour: Yellow oxide of iron
Approved colours used in hard gelatin capsule shell.

THERAPEUTIC INDICATIONS:

This drug is used in the treatment of diarrhea. It is used, when fluid and dietary measures are not sufficiently effective to control diarrhoea. It reduces the secretion of water and electrolytes from the intestine. This helps to reduce the amount of fluid loss from the body in diarrhoea.

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- CAUTION: Not to be sold by retail without the prescription of Registered medical practitioner.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the physician.

Racecadotril Capsules IP 100mg Technical specification:

Product Name: Racecadotril Capsules IP 100mg
Brand Name: Generic
Strength: 100mg
Dosage Form: Capsule
Route of Administration: Via Oral Route
Packing: 10 Strips of 10 Capsules Each
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antidiarrheal
Indication: This drug is used in the treatment of diarrhea. It is used, when fluid and dietary measures are not sufficiently effective to control diarrhoea.
Storage: Store at a temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Racecadotril Capsules IP 100mg


QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Racecadotril Capsules IP 100mg
    Each hard gelatin capsule contains:
    Racecadotril IP……………………100mg
    Excipients…………………………….q.s
    Colour: Yellow oxide of iron
    Approved colours used in hard
    gelatin capsule shell.

THERAPEUTIC INDICATIONS:

  • This drug is used in the treatment of diarrhea. It is used, when fluid and dietary measures are not sufficiently effective to control diarrhoea. It reduces the secretion of water and electrolytes from the intestine. This helps to reduce the amount of fluid loss from the body in diarrhoea.

CAUTION & WARNING:

  • 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- CAUTION: Not to be sold by retail without the prescription of Registered medical practitioner.

STORAGE & DOSAGE:

  • Storage: Store at a temperature not exceeding 30℃.  Store in cool, dry & dark place. Protect from Light & moisture.
  • Dosage:  As directed by the physician.