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high west distillery, llc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

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professional complementary health formulas - ancylosotma 30x ascaris 30x blastocystis hominis 30x cryptosporidium 30x dientamoeba fragilis 30x echinococcinum 30x endolimax nana 30x entamoeba histolytica 30x enterobium 30x filarinose 30x giardia lamblia 30x oxyuren 30x plasmodium 30x taenia 30x trichomonas vaginalis 30x trichinella 30x toxoplasmosis 30x - for the temporary relief of mild abdominal pain, nausea or vomiting, diarrhea, coughing or wheezing, difficulty breathing, fatigue, or feelings of discomfort or uneasiness.* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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west-ward pharmaceuticals corp - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride 250 mg - treatment of acute malaria infections :  mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax. there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae.   note: patients with acute p. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). prevention of malaria :  mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum. use of mefloquine hydrochloride tablets is contraindica

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

west-ward pharmaceutical corp - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline hydrochloride 25 mg - sertraline is indicated for the treatment of major depressive disorder in adults. the efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical trials under clinical pharmacology). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been

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

west-ward pharmaceticals corp. - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. oxcarbazepine is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see warnings and precautions (5.2, 5.3)]. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as oxcarbazepine, during pregnancy. encourage women who are taking oxcarbazepine 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/. risk summary: there are no adequate data on the developmental risks associated with the use of oxcarbaze

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west-ward pharmaceuticals corp. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride tablets should not be initiated in patients with constipation [see warnings and precautions (5.1) ]. alosetron hydrochloride tablets are contraindicated in patients with a history of the following: concomitant administration of alosetron hydrochloride tablets with fluvoxamine is contraindicated. fluvoxamine, a known strong inhibitor of cyp1a2, has been shown to increase mean alosetron plasma concentrations (auc) approximately 6

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

west-ward pharmaceuticals corp. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. oxycodone hydrochloride oral solution 100 mg per 5 ml (20 mg/ml) is indicated for the relief of pain in opioid-tolerant patients. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see warnings and precautions (5.2)] , reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: oxycodone hydrochloride oral solution is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5)] . available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studi

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

west-ward pharmaceuticals corp. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride 5 mg - dolophine tablets are indicated for the: limitations of use limitations of use methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 cfr 8.12 [see dosage and administration (2.1)]. dolophine tablets are contraindicated in patients with: risk summary the majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the childr

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

west therapeutic development llc - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - lazanda is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least: 60 mg of oral morphine per day, 25 mcg of transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid for a week or longer. patients must remain on around-the-clock opioids when taking lazanda. limitations of use: - not for use in opioid non-tolerant patients. - not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department [see contraindications ( 4)]. - as a part of the tirf rems, lazanda may be dispensed by o

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

west-ward pharmaceuticals corp. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. physicians are advised to recommend that pregnant patients taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate and well-controlled studies of clobazam in pregnant women. available data suggest that the class of benzodiazepines