Zolpidem Tartrate Tablets IP 10mg 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 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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.

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

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

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.