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

rebel distributors corp - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 10 mg - the use of metoclopramide  tablets is recommended for adults only. therapy should not exceed 12 weeks in duration. metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. the principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. if symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. as there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. metoclopramide tablets, usp are indicated for the relief of

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

rebel distributors corp - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatalpostnatal study in rats, oral doses of 60 mg/kg/day re

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

rebel distributors corp - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - 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 hydrochloride tablets, are at high risk of relapse because mefloquine hydrochloride tablets do 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). 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 contraindicated in patients

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

rebel distributors corp - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 0.5 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix pregnancy category c. there are no adequate and well-controlled studies of chantix use in pregnant women. in animal studies, chantix caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. chantix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. these exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 1 mg bid. while no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (exposures 5

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

rebel distributors corp - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 0.5 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix pregnancy category c. there are no adequate and well-controlled studies of chantix use in pregnant women. in animal studies, chantix caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. chantix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. these exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 1 mg bid. while no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (exposures 5

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

rebel distributors corp. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 30 mg - cymbalta is indicated for the treatment of major depressive disorder (mdd). the efficacy of cymbalta was established in four short term and one maintenance trial in adults [see clinical studies (14.1)] . a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. cymbalta is indicated for the treatment of generalized anxiety disorder (gad). the efficacy of cymbalta was established in three short-term trials and one maintenance trial in adults [see clinical studies (14.2)] . generalized anxiety disorder is defined by the dsm

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

rebel distributors corp - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - etodolac 400 mg - carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets are indicated: - for acute and long-term use in the management of signs and symptoms of the following:   1. osteoarthritis   2. rheumatoid arthritis - for the management of acute pain etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings , anaphylactoid reactions and precautions , preexisting asthma). etodolac tablets are contraindicated for the treatment of peri-operative pain in the settin

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

rebel distributors corp. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - propoxyphene napsylate 100 mg - propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. propoxyphene napsylate and acetaminophen tablets are a schedule iv narcotic under the u.s. controlled substances act. propoxyphene napsylate and acetaminophen tablets can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene napsylate and aceta

Australia - English - Department of Health (Therapeutic Goods Administration)

tri-med distributors pty ltd - urea (14c), quantity: 37 kbq - capsule, hard - excipient ingredients: fluorescein sodium; sucrose; maize starch; gelatin; silicon dioxide; sodium lauryl sulfate - pytest (urea [14c]breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of h. pylori infection in the human stomach.

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

rebel distributors corp - diclofenac epolamine (unii: x5f8ekl9zg) (diclofenac - unii:144o8ql0l1) - flector® patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. - flector patch is contraindicated in patients with a known hypersensitivity to diclofenac. - flector patch is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.13)]. - flector patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. - flector patch is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. teratogenic effects pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation. starting at 30 weeks gestation, avoid use of flector patch, an