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

professional complementary health formulas - candida albicans 12x, 30x, 60x - for the temporary relief of bloating, constipation, diarrhea, general fatigue, or minor joint pain due to sensitivity to phenolic compounds found in foods or other products.* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

zydus lifesciences limited - chlorpromazine hydrochloride (unii: 9wp59609j6) (chlorpromazine - unii:u42b7vya4p) - for the management of manifestations of psychotic disorders. for the treatment of schizophrenia. to control nausea and vomiting. for relief of restlessness and apprehension before surgery. for acute intermittent porphyria. as an adjunct in the treatment of tetanus. to control the manifestations of the manic type of manic-depressive illness. for relief of intractable hiccups. for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. do not use in patients with known hypersensitivity to phenothiazines. do not use in comatose states or in the presence of large amounts of central nervous system depr

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - amisulpride - oral tablet - 100mg

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

remedyrepack inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii 1 as follows: generalized, persistent anxiety (of at least 1 month continual

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

rpk pharmaceuticals, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets, (sr) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of bupropion hydrochloride extended-release tablet (sr) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies (14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release fo

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

deseret biologicals - calendula officinalis flowering top (unii: 18e7415pxq) (calendula officinalis flowering top - unii:18e7415pxq), dibasic potassium phosphate (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), arnica montana (unii: o80ty208zw) (arnica montana - unii:o80ty208zw), agave americana leaf (unii: 8511zmp5qk) (agave americana leaf - unii:8511zmp5qk), helianthemum canadense (unii: 46g3w789q3) (helianthemum canadense - unii:46g3w789q3), wood - for temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration.

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

hf acquisition co llc, dba healthfirst - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - in the treatment of parkinsonism. rigidity and tremor relieved by the apparently selective depressant action. in the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon. to relieve hypertonicity of the uterine muscle. to relax the spasm of biliary and uretered colic and bronchial spasm. to diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders. to control the crying and laughing episodes in patients with brain lesions. in cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal eeg patterns, stupor and neurological signs. in the management of peptic ulcer. in anesthesia to control excessive salivation and bronchial secretions. to control rhinorrhea of acute rhinitis or hay fever. as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, cer

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

alcon laboratories, inc. - propylene glycol (unii: 6dc9q167v3) (propylene glycol - unii:6dc9q167v3) - - for the temporary relief of burning and irritation due to dryness of the eye - for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun - for use as a protectant against further irritation or to relieve dryness of the eye - for use as a lubricant to prevent further irritation or to relieve dryness of the eye

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

bryant ranch prepack - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules, usp is indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended

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

b. braun medical inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. levetiracetam in sodium chloride injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)]. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam injection during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see human data] . in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.8)]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1,200, or 3,600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rats (1,200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3,000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1,800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1,800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1,800 mg/kg/day (6 times the mrhd on a mg/m2 basis). levetiracetam is excreted in human milk. there are no data on the effects of levetiracetam on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for levetiracetam and any potential adverse effects on the breastfed infant from levetiracetam or from the underlying maternal condition. safety and effectiveness of levetiracetam injection in patients below the age of 16 years have not been established. there were 347 subjects in clinical studies of levetiracetam that were 65 years old and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see clinical pharmacology (12.3)]. clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis [see dosage and administration (2.5)].