Raloxifene Hydrochloride Tablets USP 60mg Technical Specification:
| Product Name: | Raloxifene Hydrochloride Tablets USP 60mg |
| Brand Name: | Generic |
| Strength: | 60mg |
| 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: | Selective estrogen receptor modulators-SERMs |
| Indication: | Raloxifene is used for osteoporosis. It treats and prevents osteoporosis in postmenopausal women. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Raloxifene Hydrochloride Tablets USP 60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Raloxifene Hydrochloride Tablets USP 60mg
Each film-coated tablet contains:
Raloxifene Hydrochloride USP…………………….60mg
Excipients………………………………………………….q.s.
Colours: Sunset Yellow
THERAPEUTIC INDICATIONS:
Raloxifene is a selective estrogen receptor modulator that is used to prevent and treat osteoporosis and reduce the risk of invasive breast cancer in high-risk postmenopausal women.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistant container.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Raloxifene Hydrochloride USP…………………….60mg
Excipients………………………………………………….q.s.
Colours: Quinizarine green ss
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dispense in tight, light-resistant container.
Dosage: As directed by the Physician.

