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

strategic sourcing services, llc - guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - expectorant and nasal decongestant ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure 

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

laurus generics inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets are indicated for the treatment of partial- onset seizures in patients 1 month of age and older. levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam tablet is contraindicated in patients with a hypersensitivity to levetiracetam . reactions have included anaphylaxis and angioedema [ see warnings and precautions (5.4) ]. pregnancy exposure registry 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 during pregnancy to enroll in the

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

a-s medication solutions - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets are indicated for the treatment of partial- onset seizures in patients 1 month of age and older. levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam tablet is contraindicated in patients with a hypersensitivity to levetiracetam . reactions have included anaphylaxis and angioedema [ see warnings and precautions (5.4) ]. pregnancy exposure registry 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 during pregnancy to enroll in the north american antiepileptic drug (naaed)

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

rite aid corporation - guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - expectorant and nasal decongestant ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure 

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

leader/ cardinal health 110, inc. - guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - expectorant and nasal decongestant ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure 

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

ascend laboratories, llc - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidine tablets are indicated in adults for the: - treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). - reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2) receptor antagonists. risk summary available data with h2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administratio

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

vkt pharma private limited - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - acid reducer - relieves heartburn associated with acid indigestion and sour stomach - prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

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

mckesson corporation dba sky packaging - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke.  clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are

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

quallent pharmaceuticals health llc - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke.  clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2) ]. risk summary available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data] .there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations] . no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose [see data] .   the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, 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 disease-associated maternal and/or embryo/fetal risk   myocardial infarction and stroke are medical emergencies. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus.   labor or delivery clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. when possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade.   data human data the available data from published case reports over two decades of postmarketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.   animal data embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis. these doses, corresponding to 65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis, revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. risk summary there are no data on the presence of clopidogrel in human milk or the effects on milk production. no adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases. studies in rats have shown that clopidogrel and/or its metabolites are present in the milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for clopidogrel and any potential adverse effects on the breastfed infant from clopidogrel or from underlying maternal condition. safety and effectiveness in pediatric populations have not been established.  a randomized, placebo-controlled trial (clarinet) did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. possible factors contributing to this outcome were the dose of clopidogrel, the concomitant administration of aspirin and the late initiation of therapy following shunt palliation. it cannot be ruled out that a trial with a different design would demonstrate a clinical benefit in this patient population.   of the total number of subjects in the caprie and cure controlled clinical studies, approximately 50% of patients treated with clopidogrel were 65 years of age and older, and 15% were 75 years and older. in commit, approximately 58% of the patients treated with clopidogrel were 60 years and older, 26% of whom were 70 years and older.   the observed risk of bleeding events with clopidogrel plus aspirin versus placebo plus aspirin by age category is provided in table 1 and table 2 for the cure and commit trials, respectively [see adverse reactions (6.1) ]. no dosage adjustment is necessary in elderly patients. experience is limited in patients with severe and moderate renal impairment [see clinical pharmacology (12.2) ]. no dosage adjustment is necessary in patients with hepatic impairment [see clinical pharmacology (12.2) ].

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

strategic sourcing services, llc - guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - expectorant and nasal decongestant ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure