GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Meloxicam Capsules 5mg
2. Meloxicam Capsules 10mg
3. Meloxicam Capsules 15mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Meloxicam Capsules 5mg
Each hard gelatin capsule contains:
Meloxicam USP…………………5mg
Excipients…………………………q.s
Approved Colours are used in capsule shells.

2. Meloxicam Capsules 10mg
Each hard gelatin capsule contains:
Meloxicam USP………………………10mg
Excipients………………………………… q.s
Approved Colours are used in capsule shells.

3. Meloxicam Capsules 15mg
Each hard gelatin capsule contains:
Meloxicam USP………………………15mg
Excipients…………………………………q.s
Approved Colours are used in capsule shells.

THERAPEUTIC INDICATIONS:

Meloxicam is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Store in the original container and keep bottle tightly closed to protect from moisture.
Dispense in a tight container.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Meloxicam Capsules 15mg Technical Specification:

Product Name: Meloxicam Capsules
Brand Name: Generic
Strength: (5mg), (10mg), (15mg)
Dosage Form: Capsules (Hard gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Antirheumatic, Anti-inflammatory
Indication: Meloxicam is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).
Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Meloxicam Capsules 5mg
2. Meloxicam Capsules 10mg
3. Meloxicam Capsules 15mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Meloxicam Capsules 5mg
Each hard gelatin capsule contains:
Meloxicam USP…………………5mg
Excipients…………………………q.s
Approved Colours are used in capsule shells.

2. Meloxicam Capsules 10mg
Each hard gelatin capsule contains:
Meloxicam USP………………………10mg
Excipients………………………………… q.s
Approved Colours are used in capsule shells.

3. Meloxicam Capsules 15mg
Each hard gelatin capsule contains:
Meloxicam USP………………………15mg
Excipients…………………………………q.s
Approved Colours are used in capsule shells.

THERAPEUTIC INDICATIONS:

Meloxicam is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Store in the original container and keep bottle tightly closed to protect from moisture.
Dispense in a tight container.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
Protect from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.