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

deseret biologicals - acetaldehyde (unii: go1n1zpr3b) (acetaldehyde - unii:go1n1zpr3b), coumarin (unii: a4vz22k1wt) (coumarin - unii:a4vz22k1wt), histamine dihydrochloride (unii: 3poa0q644u) (histamine - unii:820484n8i3), quercetin (unii: 9ikm0i5t1e) (quercetin - unii:9ikm0i5t1e), saccharomyces cerevisiae (unii: 978d8u419h) (saccharomyces cerevisiae - unii:978d8u419h), candida albicans (unii: 4d7g21hdbc) (candida albicans - unii:4d7g21hdbc), candida parapsilosis (unii: 0kz676d44n) (candida parapsilosis - unii:0kz676d44n), cortic - acetaldehyde 6 [hp_x] in 1 ml - temporary relief of symptoms related to yeast syndrome including fatigue, malaise, weakness, headaches, gi disturbance, depression and anxiety. temporary relief of symptoms related to yeast syndrome including fatigue, malaise, weakness, headaches, gi disturbance, depression and anxiety.

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

deseret biologicals, inc. - yeast mannan (unii: 91r887n59p) (yeast mannan - unii:91r887n59p) - yeast mannan 6 [hp_x] in 1 ml - for temporary relief of symptoms related to candida infection, itching, hives, nausea, confusion, mucous congestion, swelling of joints, lethargy and sensitivity to fungi.** **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 candida infection, itching, hives, nausea, confusion, mucous congestion, swelling of joints, lethargy and sensitivity to fungi.** **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)

deseret biolgicals, inc. - yeast mannan (unii: 91r887n59p) (yeast mannan - unii:91r887n59p) - yeast mannan 6 [hp_x] in 1 ml - for temporary relief of symptoms related to candida infection, itching, hives, nausea, confusion, sleep disorder, mucous congestion, swelling of joints, lethargy and sensitivity to fungi. for temporary relief of symptoms related to candida infection, itching, hives, nausea, confusion, sleep disorder, mucous congestion, swelling of joints, lethargy and sensitivity to fungi.

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

jubilant hollisterstier llc - yeast (unii: 3ny3sm6b8u) (yeast - unii:3ny3sm6b8u) - equus caballus hair 0.01 g in 1 ml - non-standardized allergenic extracts are indicated for: - skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens. non-standardized allergenic extracts are indicated for: - immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for allergen specific ige antibodies for the specific corresponding allergens. non-standardized allergenic extracts are contraindicated in individuals with the following conditions: - severe, unstable or uncontrolled asthma. - history of any severe systemic reaction to the allergen extract when administered for diagnosis or treatment. - medical conditions that reduce the ability to survive anaphylaxis. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes.  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%, respecti

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

remedyrepack inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies ( 14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate is contraindicated in patients - who have experienced complex sleep behaviors after taking zolpidem tartrate [see warnings and precautions ( 5.1)] . - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions ( 5.4)] . risk summary neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see clinical considerations and data] . published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see data] . oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations fetal/neonatal adverse reactions zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. monitor neonates exposed to zolpidem tartrate tablets during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. data human data published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects. there are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. these cases required artificial ventilation or intratracheal intubation. the majority of neonates recovered within hours to a few weeks after birth once treated. zolpidem has been shown to cross the placenta. animal data oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended human dose (mrhd) of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the mrhd based on mg/m 2 body surface area. oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the mrhd of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the mrhd based on mg/m 2 body surface area. oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the mrhd of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the mrhd based on mg/m 2 body surface area. risk summary limited data from published literature report the presence of zolpidem in human milk. there are reports of excess sedation in infants exposed to zolpidem through breastmilk [see clinical considerations] . there is no information on the effects of zolpidem on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zolpidem tartrate tablets and any potential adverse effects on the breastfed infant from zolpidem tartrate tablets or from the underlying maternal condition. clinical considerations infants exposed to zolpidem tartrate tablets through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after zolpidem tartrate tablets administration in order to minimize drug exposure to a breast fed infant. zolpidem tartrate is not recommended for use in children. safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. in an 8-week study in pediatric patients (aged 6 to 17 years) with insomnia associated with attention-deficit/hyperactivity disorder (adhd) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see warnings and precautions ( 5.5)] . ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. a total of 154 patients in u.s. controlled clinical trials and 897 patients in non-u.s. clinical trials who received zolpidem were ≥60 years of age. for a pool of u.s. patients receiving zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related). dizziness 3% 0% drowsiness 5% 2% diarrhea 3% 1% a total of 30/1,959 (1.5%) non-u.s. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥70 years of age. of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. a total of 24/1,959 (1.2%) non-u.s. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg. the dose of zolpidem tartrate in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see warnings and precautions ( 5.2)] . women clear zolpidem tartrate from the body at a lower rate than men. c max and auc parameters of zolpidem were approximately 45% higher at the same dose in female subjects compared with male subjects. given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of zolpidem tartrate for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg. in geriatric patients, clearance of zolpidem is similar in men and women. the recommended dose of zolpidem tartrate in geriatric patients is 5 mg regardless of gender. the recommended dose of zolpidem tartrate in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. avoid zolpidem tartrate use in patients with severe hepatic impairment as it may contribute to encephalopathy [see dosage and administration ( 2.2), warnings and precautions ( 5.8), clinical pharmacology ( 12.3)] . zolpidem tartrate is classified as a schedule iv controlled substance by federal regulation. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo. because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic. use of zolpidem tartrate may lead to the development of physical and/or psychological dependence. the risk of dependence increases with dose and duration of treatment. the risk of abuse and dependence is also greater in patients with a history of alcohol or drug abuse. zolpidem tartrate should be used with extreme caution in patients with current or past alcohol or drug abuse physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. these reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, convulsions, and delirium. the following adverse events, which are considered to meet the dsm-iii-r criteria for uncomplicated sedative/hypnotic withdrawal, were reported during clinical trials with zolpidem tartrate following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. these reported adverse events occurred at an incidence of 1% or less. however, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. there have been postmarketing reports of abuse, dependence and withdrawal with zolpidem.

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

phytopia co., ltd. - angelica sinensis root (unii: b66f4574ug) (angelica sinensis root - unii:b66f4574ug) - use for treatment of loose skin, such as breast, face, and lower body. directions apply on skin and gentle massage around affected area.

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

king bio inc. - aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), bellis perennis (unii: 2hu33i03uy) (bellis perennis - unii:2hu33i03uy), bromine (unii: sbv4xy874g) (bromine - unii:sbv4xy874g), bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), conium maculatum flowering top (unii: q28r5gf371) (conium maculatum flowering top - unii:q28r5gf371), iodine (unii: 9679tc07x4) (iodine - unii:96 - uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing. uses for temporary relief of symptoms:  - inflammation - tenderness - lumpiness - hardness - soreness - cracked or irritated nipples from nursing - shrinking breasts following nursing

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

new sun inc. - picea mariana resin (unii: 71aov0w131) (picea mariana resin - unii:71aov0w131), antimony trisulfide (unii: f79059a38u) (antimony trisulfide - unii:f79059a38u), asafetida (unii: w9fza51as1) (asafetida - unii:w9fza51as1), baptisia tinctoria root (unii: 5ef0hwi5wu) (baptisia tinctoria root - unii:5ef0hwi5wu), sodium borate (unii: 91mbz8h3qo) (borate ion - unii:44oae30d22), candida albicans (unii: 4d7g21hdbc) (candida albicans - unii:4d7g21hdbc), lachesis muta venom (unii: vsw71ss07i) (lachesis muta veno - indications: for temporary relief of yeast or fungal overgrowths in both male and female, and the symptoms of: candida albicans, infections, fatigue, congestion, headaches, indigestion, poor bowel function, achy joints, poor memory, sensitive emotions, changing moods, mold sensitivity. indications: for temporary relief of yeast or fungal overgrowths in both male and female, and the symptoms of: - candida albicans - infections - fatigue - congestion - headaches - indigestion - poor bowel function - achy joints - poor memory - sensitive emotions - changing moods - mold sensitivity

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

newton laboratories, inc. - bufo bufo cutaneous gland (unii: q59qu6n72q) (bufo bufo cutaneous gland - unii:q59qu6n72q), apis mellifera (unii: 7s82p3r43z) (apis mellifera - unii:7s82p3r43z), asterias rubens (unii: a7fyy9q742) (asterias rubens - unii:a7fyy9q742), atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), oyster shell calcium carbonate, crude (unii: 2e32821g6i) (oyster shell calcium carbonate, crude - unii:2e32821g6i), matricaria - formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling. breast care: formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

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

newton laboratories, inc. - bufo bufo cutaneous gland (unii: q59qu6n72q) (bufo bufo cutaneous gland - unii:q59qu6n72q), apis mellifera (unii: 7s82p3r43z) (apis mellifera - unii:7s82p3r43z), asterias rubens (unii: a7fyy9q742) (asterias rubens - unii:a7fyy9q742), atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), oyster shell calcium carbonate, crude (unii: 2e32821g6i) (oyster shell calcium carbonate, crude - unii:2e32821g6i), matricaria - formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling. breast care: formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.