Lithium Carbonate Sustained Release Tablets USP 400mg Technical Specification:

Product Name:Lithium Carbonate Sustained Release Tablets USP 400mg
Brand Name:Generic
Strength:300mg, 400mg
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 Sustained Release Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Lithium Carbonate Sustained Release Tablets USP 400mg
    Each sustained release tablet contains:
    Lithium Carbonate USP…………………400mg
    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

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Lithium Carbonate Sustained Release Tablets USP 300mg
B) Lithium Carbonate Sustained Release Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Lithium Carbonate Sustained Release Tablets USP 300mg
Each sustained release tablet contains:
Lithium Carbonate USP………………300mg
Excipients……………………………………q.s.

B) Lithium Carbonate Sustained Release Tablets USP 400mg
Each sustained release tablet contains:
Lithium Carbonate USP…………………400mg
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