Zolpidem Tartrate Tablets IP 5mg Technical Specification:
| Product Name: | Zolpidem Tartrate Tablets IP |
| Brand Name: | (ZOLPITAJ) |
| Strength: | (5mg), (10mg) |
| Dosage Form: | Tablets(Film-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: | Zolpidem is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient. |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Zolpidem Tartrate Tablets IP 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Zolpidem Tartrate Tablets IP 5mg
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……5mg
Excipients……………………………..q.s
Colour: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Zolpidem is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.
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: 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.
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Zolpidem Tartrate Tablets IP 5mg
2. Zolpidem Tartrate Tablets IP 10mg
2. Zolpidem Tartrate Tablets IP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Zolpidem Tartrate Tablets IP 5mg
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……5mg
Excipients……………………………..q.s
Colour: Sunset yellow FCF
2. Zolpidem Tartrate Tablets IP 10mg
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……10mg
Excipients…………………….………..q.s
Colour: Sunset yellow
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……5mg
Excipients……………………………..q.s
Colour: Sunset yellow FCF
2. Zolpidem Tartrate Tablets IP 10mg
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……10mg
Excipients…………………….………..q.s
Colour: Sunset yellow
THERAPEUTIC INDICATIONS:
Zolpidem is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.
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: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H1 CAUTION: 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.
Protect from Light and moisture.
Dosage: As directed by the Physician.
