Lithium Carbonate 300 MG Oral Capsule

1 INDICATIONS AND USAGE Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] • Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) • Maintenance treatment in patients 7 years and older ( 1 )

glenmark pharmaceuticals inc., usa

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] toxicity to various agents` `[3] fatigue` `[4] off label use` `[5] pain` `[6] nausea` `[7] drug interaction` `[8] headache` `[9] condition aggravated` `[10] vomiting`

4 years ago

CAPSULE PINK G221 300

16 HOW SUPPLIED/STORAGE AND HANDLING

LITHIUM CARBONATE capsules, USP 150 mg supplied as light gray hard gelatin capsules imprinted with ‘150’ on the body and ‘G220’ on the cap, filled with white to off-white granules. NDC 68462-220-11: Unit-dose box of 100 capsules (10 blister cards each containing 10 capsules). NDC 68462-220-01: Bottles of 100 capsules. 300 mg supplied as pink hard gelatin capsules imprinted with ‘300’ on the body and ‘G221’ on the cap, filled with white to off-white granules. NDC 68462-221-11: Unit-dose box of 100 capsules (10 blister cards each containing 10 capsules). NDC 68462-221-01: Bottles of 100 capsules. NDC 68462-221-10: Bottles of 1000 capsules. 600 mg supplied as hard gelatin capsules, pink cap imprinted with ‘G222’ and light gray body imprinted with ‘600’, filled with white to off-white granules. NDC 68462-222-11: Unit-dose box of 100 capsules (10 blister cards each containing 10 capsules). NDC 68462-222-01: Bottles of 100 capsules. Storage and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.

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