Calcium & Cholecalciferol Tablets BP Technical Specification:
| Product Name: | Calcium & Cholecalciferol Tablets BP |
| Brand Name: | Generic |
| Strength: | 500mg+200 IU |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 50s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Calcium & Vitamin D supplement |
| Indication: | To treat low blood calcium levels |
| Storage: | Store below 30°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Calcium & Cholecalciferol Tablets BP (500mg+200 IU)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Calcium & Cholecalciferol Tablets BP (500mg+250 IU)
Each Film Coated Tablet Contains:
Calcium Carbonate BP………………………………1250 mg.
eq. to Elemental Calcium…………………….…….500 mg.
Cholecalciferol (Vitamin D3) BP…………………250 IU
Excipients……………………………………Q.S.
Colour: Titanium Dioxide BP
THERAPEUTIC INDICATIONS:
It may be used to treat conditions caused by low calcium levels such as bone loss (osteoporosis), weak bones (osteomalacia /rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany).
CAUTION & WARNING:
CAUTION:
Keep the medicine out of reach of children.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISATERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store below 30°C in cool, dark and dry place, protected from light.
DOSAGE: As directed by physician.