GENERIC NAME OF THE MEDICINAL PRODUCT

A. Zaleplon Capsules USP 5mg
B. Zaleplon Capsules USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Zaleplon Capsules USP 5mg Composition:
Each capsule contains:
Zaleplon USP……………………5mg
Excipients………………………....q.s
Colour: Tartrazine
Approved Colour used in capsule shell.

B) Zaleplon Capsules USP 10mg Composition:
Each capsule contains:
Zaleplon USP……………………10mg
Excipients………………………....q.s
Colour: carmoisine & Erythrosine
Approved Colour used in capsule shell.

THERAPEUTIC INDICATIONS:

This drug is used on a short-term basis to treat insomnia (difficulty falling asleep). Zaleplon does not help you to stay asleep longer or decrease the number of times that you awaken during the night. It works by slowing activity in the brain to allow sleep.

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.

STORAGE & DOSAGE:

Storage: Store at controlled room temperature 20℃ to 25℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the physician.

Zaleplon Capsules USP 10mg Technical specification:

Product Name: Zaleplon Capsules USP
Brand Name: Generic
Strength: 10mg, 5mg
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, FCF, COPP, Stability Studies, GMP
Therapeutic use: Hypnotics
Indication: This drug is used on a short-term basis to treat insomnia (difficulty falling asleep). Zaleplon does not help you to stay asleep longer or decrease the number of times that you awaken during the night. It works by slowing activity in the brain to allow sleep.
Storage: Store at controlled room temperature 20℃ to 25℃.  Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Zaleplon Capsules USP 5mg
Zaleplon Capsules USP 10mg


QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Zaleplon Capsules USP 5mg Composition:
    Each capsule contains:
    Zaleplon USP……………………5mg
    Excipients………………………….q.s
    Colour: Tartrazine
    Approved Colour used in capsule shell.
  2. Zaleplon Capsules USP 10mg Composition:
    Each capsule contains:
    Zaleplon USP……………………10mg
    Excipients………………………….q.s
    Colour: carmoisine & Erythrosine
    Approved Colour used in capsule shell.

THERAPEUTIC INDICATIONS:

  • This drug is used on a short-term basis to treat insomnia (difficulty falling asleep). Zaleplon does not help you to stay asleep longer or decrease the number of times that you awaken during the night. It works by slowing activity in the brain to allow sleep.

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.

STORAGE & DOSAGE:

  • Storage:  Store at controlled room temperature 20℃ to 25℃.Store in cool, dry & dark place. Protect from Light & moisture.
  • Dosage: As directed by the physician.