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

aphena pharma solutions - tennessee, llc - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride 100 mg - amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine does not completely prevent the host immune response to influenza a infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. following vaccination during an influenza a outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains especial

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

aphena pharma solutions - tennessee, llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets, usp are indicated for the management of moderate to moderately severe pain in adults. tramadol hydrochloride tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. tramadol hydrochloride tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride tablets can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include

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

clinical solutions wholesale - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets usp, is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets usp is contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets usp should

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

aphena pharma solutions - tennessee, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also precautions).

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

braintree laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium cation - unii:lyr4m0nh37), potassium sulfate (unii: 1k573lc5tv) (potassium cation - unii:295o53k152), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate 17.5 g in 1 ml - suprep bowel prep kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. suprep bowel prep kit is contraindicated in the following conditions: - gastrointestinal obstruction or ileus  [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precaution ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in suprep bowel prep kit risk summary there are no available data on suprep bowel prep kit use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (suprep bowel prep kit). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies

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

aphena pharma solutions - tennessee, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii-r or dsm-iv category of major depressive disorder (seeclinical trials). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness

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

aphena pharma solutions - tennessee, llc - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules, usp are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14) ]. tamsulosin hydrochloride capsules, usp are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules, usp are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules, usp. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2) ]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsu

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

clinical solutions wholesale, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - 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 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 to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an maoi (intended to treat psychiatric disorders) is also contr

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

aphena pharma solutions - tennessee, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules 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 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 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 to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules are contraindicated

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

mckesson contract packaging - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 750 mg