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

burel pharmaceuticals, inc - hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x) - hyoscyamine sulfate 0.12 mg

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

burel pharmaceuticals, llc - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. abacavir and lamivudine tablets are contraindicated in patients: • who have the hla-b*5701 allele [see warnings and precautions (5.1)]. • with prior hypersensitivity reaction to abacavir [see warnings and precautions (5.1)] or lamivudine. • with moderate or severe hepatic impairment [see use in specific populations (8.7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atl

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

burel pharmaceuticals, inc - isometheptene mucate (unii: 8o120fds6p) (isometheptene - unii:y7l24thh6t) - isometheptene mucate 65 mg

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

burel pharmaceuticals, inc - isometheptene mucate (unii: 8o120fds6p) (isometheptene - unii:y7l24thh6t) - isometheptene mucate 65 mg

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

burel pharmaceuticals, llc - loxapine succinate (unii: x59sg0mryu) (loxapine - unii:ler583670j) - loxapine capsules are indicated for the treatment of schizophrenia. the efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects. loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.

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

burel pharmaceuticals, inc - phenazopyridine hydrochloride (unii: 0ewg668w17) (phenazopyridine - unii:k2j09emj52) - phenazopyridine hydrochloride 100 mg

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

burel pharmaceuticals, inc - brompheniramine maleate (unii: ixa7c9zn03) (brompheniramine - unii:h57g17p2fn) - brompheniramine maleate 4 mg

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

burel pharmaceuticals, inc - guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq) - guaifenesin 380 mg

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

burel pharmaceuticals, inc - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - dextromethorphan hydrobromide 15 mg

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

burel pharmaceuticals, llc - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - acyclovir ointment usp 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation. clinical studies of acyclovir ointment 5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. systemic absorption of acyclovir after topical administration is minimal (see clinical pharmacology). safety and effectiveness in pediatric patients have not been established.