United States - English - NLM (National Library of Medicine)

lake eire medical & surgical supply dba quality care products llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 750 mg - levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. this product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam tablets. the abuse and dependence potential of levetiracetam has not been evaluated in human studies.

United States - English - NLM (National Library of Medicine)

american health packaging - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 300 mg - quetiapine tablets usp are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets usp in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets usp for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.1 )]. quetiapine tablets usp are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies ( 14.2 )]. quetiapine tablets usp are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult

United States - English - NLM (National Library of Medicine)

a-s medication solutions - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 100 mg - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies (14)] : - major depressive disorder (mdd) - obsessive-compulsive disorder (ocd) - panic disorder (pd) - posttraumatic stress disorder (ptsd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) sertraline hydrochloride tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)]. - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)] . risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator popu

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine tablets usp are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets usp in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets usp for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1 )]. quetiapine tablets usp are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2 )]. quetiapine tablets usp are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult p

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 750 mg - levetiracetam tablets usp are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc.'s levetiracetam tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. levetiracetam tablets usp are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. none. levetiracetam levels may decrease during pregnancy [see warnings and precautions (5.9) ]. pregnancy category c there a

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam tablets usp are indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)] . meloxicam tablets usp are indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1)] . meloxicam tablets usp are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [see dosage and administration (2.4) and  clinical studies (14.2)] . meloxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery by

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies ( 14.1)]. bupropion hydrochloride extended-release tablets (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets (xl) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. this product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam tablets. the abuse and dependence potential of levetiracetam has not been evaluated in human studies.

United States - English - NLM (National Library of Medicine)

sterling-knight pharmaceuticals, llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).  diclofenac sodium is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. [see warnings and precautions (5.7,5.9)]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7,5.8)]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. pregnancy: use of nsaids during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids in pregnant women starting at 30 weeks gestation (5.10, 8.1) infertility: nsaids are associated with reversible inferti

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies ( 14)] : - major depressive disorder (mdd) - obsessive-compulsive disorder (ocd) - panic disorder (pd) - posttraumatic stress disorder (ptsd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) sertraline hydrochloride tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)] . - taking pimozide [see drug interactions ( 7.1)]. - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions ( 6.1, 6.2)] . risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in compara