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

proficient rx lp - brompheniramine maleate (unii: ixa7c9zn03) (brompheniramine - unii:h57g17p2fn), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. hypersensitivity to any of the ingredients. do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (maois) (see drug interactions ). antihistamines should not be used to treat lower respiratory tract conditions including asthma.

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

preferred pharmaceuticals inc. - brompheniramine maleate (unii: ixa7c9zn03) (brompheniramine - unii:h57g17p2fn), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. hypersensitivity to any of the ingredients. do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (maois) (see drug interactions ). antihistamines should not be used to treat lower respiratory tract conditions including asthma.

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

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer b.v. - ibuprofen 200 mg; pseudoephedrine hydrochloride 30 mg - coated tablet - 200 mg - 30 mg - ibuprofen 200 mg; pseudoephedrine hydrochloride 30 mg - pseudoephedrine, combinations; m01ae51 ibuprofen, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

diapharm gmbh & co. kg - ibuprofen; pseudoephedrine hydrochloride - film-coated tablet - 200/30 milligram(s) - other cold preparations

Malta - English - Malta Medicines Authority

laboratoire aguettant 1 rue alexander fleming, 69007 lyon, france - ephedrine hydrochloride - solution for injection - ephedrine hydrochloride 30 mg/ml - cardiac therapy

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

pfizer australia pty ltd - ephedrine sulfate, quantity: 30 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - ephedrine is indicated in the treatment of shock unresponsive to fluid replacement. it is also indicated in the treatment of hypotension secondary to spinal anaesthesia. ephedrine sulfate injection has also been used in the treatment of bronchial asthma and reversible bronchospasm although more selective agents (beta adrenergic agonists) are now available.

Canada - English - Health Canada

auro pharma inc - ephedrine sulfate - solution - 50mg - ephedrine sulfate 50mg

Canada - English - Health Canada

eugia pharma inc. - ephedrine sulfate - solution - 50mg - ephedrine sulfate 50mg

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

par pharmaceutical, inc. - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.  however, there are clinical considerations (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively (see data) .  the estimated background risk of major birth defects and miscarriage for the indicated population 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 disease-associated maternal and/or embryofetal risk untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. a decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these reports describe umbilical artery ph of ≤7.2 at the time of delivery [see clinical pharmacology (12.3) ]. monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. monitoring of infant’s acid‐base status is warranted to ensure that an episode of acidosis is acute and reversible. data animal data decreased fetal body weights were observed when pregnant rats were administered intravenous bolus doses of 60 mg/kg ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg based on body surface area) from gestation day 6-17. this dose was associated with evidence of maternal toxicity (decreased body weight of dams and abnormal head movements). no malformations or fetal deaths were noted at this dose. no effects on fetal body weight were noted at 10 mg/kg (1.9 times the mrhd of 50 mg). no evidence of malformations or embryo-fetal toxicity were noted in pregnant rabbits administered intravenous bolus doses up to 20 mg/kg ephedrine sulfate (7.7 times the maximum recommended human dose (mrhd) of 50 mg based on body surface area) from gestation day 6-20. this dose was associated with expected pharmacological maternal effects (increased respiration rate, dilated pupils, piloerection). decreased fetal survival and body weights in the presence of maternal toxicity (increased mortality) were noted when pregnant dams were administered intravenous bolus doses of 60 mg/kg epinephrine sulfate (approximately 12 times the mrhd based on body surface area) from gd 6 through lactation day 20. no adverse effects were noted at 10 mg/kg (1.9 times the mrhd). risk summary a single published case report indicates that ephedrine is present in human milk. however, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. animal toxicity data in a study in which juvenile rats were administered intravenous bolus doses of 2, 10, or 60 mg/kg ephedrine sulfate daily from postnatal day 35 to 56, an increased incidence of mortality was noted at the high dose of 60 mg/kg.  the no-adverse-effect level was 10 mg/kg (approximately 1.9 times a maximum daily dose of 50 mg in a 60 kg person based on body surface area). clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ephedrine and its metabolite are excreted in urine. in patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. monitor patients with renal impairment carefully after the initial bolus dose for adverse events.