GENERIC NAME OF THE MEDICINAL PRODUCT:
2. Nitrazepam Tablets IP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Un-coated tablet contains:
Nitrazepam IP……….……5mg
Excipients…………………..q.s
Colour: Titanium Dioxide IP
2. Nitrazepam Tablets IP 10mg
Each Un-coated tablet contains:
Nitrazepam IP……….……10mg
Excipients…………………..q.s
Colour: Sunset yellow
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H1 CAUTION: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Protect from Light and moisture.
Dosage: As directed by the Physician.
Nitrazepam Tablets IP 5mg Technical Specification:
| Product Name: | Nitrazepam Tablets IP |
| Brand Name: | Generic |
| Strength: | (5mg), (10mg) |
| Dosage Form: | Tablets(Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Sedative-hypnotics |
| Indication: | Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable. |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Nitrazepam Tablets IP 5mg
2. Nitrazepam Tablets IP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Nitrazepam Tablets IP 5mg
Each Un-coated tablet contains:
Nitrazepam IP……….……5mg
Excipients…………………..q.s
Colour: Titanium Dioxide IP
2. Nitrazepam Tablets IP 10mg
Each Un-coated tablet contains:
Nitrazepam IP……….……10mg
Excipients…………………..q.s
Colour: Sunset yellow
THERAPEUTIC INDICATIONS:
Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H1 CAUTION: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.
