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

somerset therapeutics, llc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: -   as an adjunct to general anesthesia -   to facilitate tracheal intubation -   to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine chloride injection is contraindicated: -   in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] -   in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)] -   after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] -   in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

reckitt benckiser healthcare (uk) ltd - choline salicylate - oromucosal gel - 87mg/1gram

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

hikma pharmaceuticals usa inc. - succinylcholine chloride dihydrate (unii: 8l0s1g435e) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation succinylcholine chloride injection is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5. 2) ] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports and case series over several decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation.  if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. the estimated background risk of major birth defects and miscarriage for the indicated population is 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 2-4% and 15-20%, respectively. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of succinylcholine. therefore, some pregnant patients may experience prolonged apnea. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase, in the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for succinylcholine chloride injection and any potential adverse effects on the breastfed infant from succinylcholine chloride injection or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of succinylcholine chloride injection in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of succinylcholine chloride injection in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of succinylcholine chloride injection in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride 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.

Malta - English - Medicines Authority

reckitt benckiser healthcare (uk) limited 103-105 bath road slough sl1 3uh, united kingdom - choline salicylate, cetalkonium chloride - oromucosal gel - cetalkonium chloride 0.01 % (w/w) choline salicylate 8.714 % (w/w) - analgesics

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

the kroger co - guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), choline salicylate (unii: kd510k1iqw) (salicylic acid - unii:o414pz4lpz) - purpose pain reliever / fever reducer expectorant nasal decongestant uses temporarily relieves nasal congestion due to common cold, hay fever and other upper respiratory allergies: - nasal congestion - minor aches and pains - headache - temorarily reduces fever - helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive do not use - if you have ever had an allergic reaction to salicylates (including aspirin) or other pain reliever/fever reducer. - if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. - if you have ever had an allergic reaction to this product or any of its ingredients - in children under 12 years of age stop use and ask a doctor if - an allerg

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

the kroger co - diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m), choline salicylate (unii: kd510k1iqw) (salicylic acid - unii:o414pz4lpz), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - purpose pain reliever / fever reducer antihistamine nasal decongestant uses temporarily relieves these common cold and flu symptoms: - nasal congestion - minor aches and pains - sore throat - headache - runny nose - sneezing - watery eyes - temporarily reduces fever do not use - if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer. - with any other drug containing diphenhydramine, even one used on the skin - if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. - in children under 12 years of age stop use and ask a doctor if - an allergic reaction occurs. seek medical help right away. - pain, cough, or nasal congestion gets worse or lasts more than 7 days - fever gets worse or

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

gm pharmaceuticals, inc - choline salicylate (unii: kd510k1iqw) (salicylic acid - unii:o414pz4lpz), diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m) - pain reliever nighttime sleep-aid - for relief of occasional sleeplessness when associated with minor aches and pains - helps you fall asleep

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

gm pharmaceuticals, inc - choline salicylate (unii: kd510k1iqw) (salicylic acid - unii:o414pz4lpz), diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - pain reliever/fever reducer antihistamine nasal decongestant nonsteroidal anti-inflammatory drug* ▪temporarily relieves these common cold and flu symptoms: ▪ nasal congestion ▪ minor aches and pains ▪ runny nose ▪ sneezing ▪ watery eyes ▪ sore throat ▪ headache ▪ temporarily reduces fever

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

topco associates llc - choline salicylate (unii: kd510k1iqw) (salicylic acid - unii:o414pz4lpz), diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - pain reliever/fever reducer antihistamine nasal decongestant nonsteroidal anti-inflammatory drug* temporarily relieves these common cold and flu symptoms: ▪ nasal congestion ▪ minor aches and pains ▪ runny nose ▪ sneezing ▪ watery eyes ▪ sore throat ▪ headache ▪ temporarily reduces fever

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

topco associates llc - choline salicylate (unii: kd510k1iqw) (salicylic acid - unii:o414pz4lpz), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - pain reliever/fever reducer cough suppressant expectorant nasal decongestant *nonsteroidal anti-inflammatory drug temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive