| Product Name: | Lithium Carbonate Extended Release Tablets USP |
| Brand Name: | Generic |
| Strength: | 300mg, 400mg, 450mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 2s, 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidepressants, Central nervous system |
| Indication: | Lithium Carbonate is used to treat manic-depressive disorder (bipolar disorder). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lithium Carbonate Extended Release Tablets USP 300mg
- Lithium Carbonate Extended Release Tablets USP 400mg
- Lithium Carbonate Extended Release Tablets USP 450mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lithium Carbonate Extended Release Tablets USP 300mg
Each Extended release tablet contains:
Lithium Carbonate USP………………300mg
Excipients……………………………………q.s. - Lithium Carbonate Extended Release Tablets USP 400mg
Each Extended release tablet contains:
Lithium Carbonate USP…………………400mg
Excipients………………………………………q.s. - Lithium Carbonate Extended Release Tablets USP 450mg
Each Extended release tablet contains:
Lithium Carbonate USP…………………450mg
Excipients………………………………………q.s.
THERAPEUTIC INDICATIONS:
Lithium Carbonate is used to treat manic-depressive disorder (bipolar disorder). It works to stabilize the mood and reduce extremes in behavior by restoring the balance of certain natural substances (neurotransmitters) in the brain.
CAUTION & WARNING:
CAUTION:
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:
Storage: Store the unit-dose blister pack in this bottle with the cap tightly secured till both tablets have been consumed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.