GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Labetalol Hydrochloride Injection USP 5mg/1ml
B. Labetalol Hydrochloride Injection USP 20mg/4ml
C. Labetalol Hydrochloride Injection USP 100mg/20ml
D. Labetalol Hydrochloride Injection USP 200mg/40ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Labetalol Hydrochloride Injection USP 5mg/1ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP………....45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………….0.80mg
Propylparaben USP…………………..0.10mg
Water for Injection USP…………...q.s

B. Labetalol Hydrochloride Injection USP 20mg/4ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP…………….…0.10mg
Methylparaben USP…………………..0.80mg
Propylparaben USP………………......0.10mg
Water for Injection USP……………..q.s

C. Labetalol Hydrochloride Injection USP 100mg/20ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP………………...0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP……….….q.s


D. Labetalol Hydrochloride Injection USP 200mg/40ml
Each ml contains:
Labetalol Hydrochloride USP…….5mg
Dextrose Anhydrous USP……..…..45mg
Edetate disodium USP………………0.10mg
Methylparaben USP…………….…..0.80mg
Propylparaben USP………………....0.10mg
Water for Injection USP…………..q.s

THERAPEUTIC INDICATIONS:

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

DIRECTION OF USE:

For Intravenous use only.
See package insert for usual dosage.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Labetalol Hydrochloride Injection USP 100mg/20ml Technical Specification:

Product Name:Labetalol Hydrochloride Injection USP
Brand Name:Generic
Strength:5mg/1ml, 20mg/4ml, 100mg/20ml, 200mg/40ml
Dosage Form:Liquid Injection (Sterile)
Packing:5mg/1ml (Single Dose Vial/Ampoule)
20mg/4ml (Single Dose Vial/Ampoule)
100mg/20ml (Multi Dose Vial)
200mg/40ml (Multi Dose Vial)
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Hypertensive
Indication: Labetalol Hydrochloride Injection is indicated for control of blood pressure in severe hypertension.
Storage:Store at 20°C to 25°C (68°F to 77°F). Store in a cool and dry place. Improper storage may be deteriorate the product. Protect from freezing and light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Labetalol Hydrochloride Injection USP 100mg/20ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Labetalol Hydrochloride Injection USP 100mg/20ml
    Each ml contains:
    Labetalol Hydrochloride USP…….5mg
    Dextrose Anhydrous USP………….45mg
    Edetate disodium USP………………0.10mg
    Methylparaben USP………………….0.80mg
    Propylparaben USP…………………..0.10mg
    Water for Injection USP………………q.s

THERAPEUTIC INDICATIONS:

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

DIRECTION OF USE:

For Intravenous use only.
See package insert for usual dosage.

CAUTION & Warning:

CAUTION: This injection should not be used if it contains visible particulate matter.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Store in a cool and dry place.
Improper storage may be deteriorate the product.
Protect from freezing and light.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.