GENERIC NAME OF MEDICINAL PRODUCT:

A. Labetalol Hydrochloride Injection IP 5mg/1ml
B. Labetalol Hydrochloride Injection IP 20mg/4ml
C. Labetalol Hydrochloride Injection IP 100mg/20ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Labetalol Hydrochloride Injection IP 5mg/1ml
Each ml contains:
Labetalol Hydrochloride IP…..5mg
Water for Injections IP…………..q.s

B. Labetalol Hydrochloride Injection IP 20mg/4ml
Each ml contains:
Labetalol Hydrochloride IP…..5mg
Water for Injections IP……….…q.s


C. Labetalol Hydrochloride Injection IP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride IP…..5mg
Water for Injections IP…….……q.s

THERAPEUTIC INDICATION:

Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.

DIRECTION OF USE:

For Intravenous use only.
See package insert for dosage information and direction for use.

CAUTION AND SCHEDULE:

CAUTION: The solution must be clear and particle free at the time of use.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE:
Store below 25℃.
Store in a cool and dry place.
protected from light.
Do not freeze.
Improper storage may be deteriorate the product.
DOSAGE: As directed by the Physician.

Labetalol Hydrochloride Injection IP 20mg/4ml Technical Specification:

Product Name:Labetalol Hydrochloride Injection IP
Brand Name:Generic
Strength:5mg/1ml, 20mg/4ml, 100mg/20ml
Dosage Form:Liquid Injection
Packing:5mg/1ml (Single Dose Vial/Ampoule)
20mg/4ml (Single Dose Vial/Ampoule)

100mg/20ml (Multi Dose Vial/Ampoule)
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-Hypertensive
Indication: Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
Storage:Store below 25℃. Store in a cool and dry place. protected from light. Do not freeze. Improper storage may be deteriorate the product.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Labetalol Hydrochloride Injection IP 20mg/4ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Labetalol Hydrochloride Injection IP 20mg/4ml
    Each ml contains:
    Labetalol Hydrochloride IP…..5mg
    Water for Injections IP………..q.s

THERAPEUTIC INDICATION:

Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.

DIRECTION OF USE:

For Intravenous use only.
See package insert for dosage information and direction for use.

CAUTION AND SCHEDULE:

CAUTION: The solution must be clear and particle free at the time of use.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25℃.
Store in a cool and dry place.
protected from light.
Do not freeze.
Improper storage may be deteriorate the product.

DOSAGE: As directed by the Physician.