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greenbrier international, inc - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - oxymetazoline hydrochloride .2 mg in .4 ml - uses temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies - temporarily relieves sinus congestion and pressure - shrinks swollen nasal membranes so you can breathe more freely stop use and ask a doctor if symptoms persist directions - adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. do not exceed 2 doses in any 24-hour period. - children under 6 years of age: ask a doctor. shake well before use. remove safety seal. to open, rotate cap to align the marks. squeeze cap on both sides in a counter-clockwise turn and pull off to remove. to spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. without tilting the head, insert nozzle into nostril. fully depress rim with a firm, even stroke and sniff deeply. wipe nozzle clean after use and snap cap back onto the bottle.

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

united exchange corp. - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - oxymetazoline hydrochloride 0.05 mg in 100 ml - uses temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies - temprarily relievves sinus congestion and pressure - shrinks swollen nasal membranes so you can breathe more freely stop use and ask a doctor if symptoms persist directions - adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. do not exceed 2 doses in any 24-hour period. - children under 8 years of age: ask a doctor. shake well before use. to open, rotate cap to align the marks. squeeze cap on both sides in a counter-clockwise turn and pull off to remove. to spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. without tiliting the head, insert nozzle into nostril. fully depress rim with a firm, even stroke and sniff deeply. wipe nozzle clean after use and snap cap back onto the bottle.

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

greenbrier international, inc. - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - oxymetazoline hydrochloride 0.05 mg in 100 ml - uses - temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies - sinusitis - shrinks swollen nasal membranes so you can breathe more freely stop use and ask a doctor if symptoms persist directions - adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. do not exceed 2 doses in any 24-hour period. - children under 8 years of age: ask a doctor. to spray, hold bottle with thumb at base and nozzle between first and second fingers. without tilting head, insert nozzle into nostril. fully depress rim with a firm, even stroke and sniff deeply. wipe nozzle clean after use.

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

st. renatus - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv), oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - tetracaine hydrochloride 30 mg in 1 ml - kovanaze tm is indicated for regional anesthesia when performing a restorative procedure on teeth 4-13 and a-j in adults and children who weigh 40 kg or more. kovanaze is contraindicated in patients with a history of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, p -aminobenzoic acid (paba), oxymetazoline, or any other component of the product [see warnings and precautions ( 5.5)] . risk summary limited published data on tetracaine use in pregnant women are not sufficient to inform any risks. published epidemiologic studies of nasal oxymetazoline used as a decongestant during pregnancy do not identify a consistent association with any specific malformation or pattern of malformations [see data] . in animal reproduction and development studies, oxymetazoline given subcutaneously to rats during the period of organogenesis caused structural abnormalities at a dose approximately 7.6 times the exposure

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

rvl pharmaceuticals, inc. - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - upneeq is indicated for the treatment of acquired blepharoptosis in adults. none.  risk summary there are no available data on upneeq use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 7 and 278 times the maximum recommended human ophthalmic dose (mrhod), respectively, based on dose comparison. [see data] . the estimated background risks 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 2-4% and 15-20%, respectively. animal data effects on embryo-fetal development were evaluated in rats and rabbits following

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aclaris therapeutics, inc. - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - rhofade® (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. none. risk summary there are no available data on rhofade cream use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. a literature article describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline (with no decongestant exposure in the first trimester) and renal collecting system anomalies [see data] . in animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 3 times and 73 times, respectively, the exposure associated with the maximum recommended human dose (mrhd) [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. all p

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

epi health, llc - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - rhofade® (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. none. risk summary there are no available data on rhofade cream use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. a literature article describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline (with no decongestant exposure in the first trimester) and renal collecting system anomalies [see data] . in animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 3 times and 73 times, respectively, the exposure associated with the maximum recommended human dose (mrhd) [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. all pregn

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

insight pharmaceuticals llc - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - oxymetazoline 0.0005 ml in 100 ml - nasal decongestant - temporarily relieves nasal congestion due to: ▪ a cold ▪ hay fever ▪ upper respiratory allergies ▪ helps clear nasal passages; shrinks swollen membranes ▪ temporarily restores freer breathing through the nose

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

select brand distributors - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - oxymetazoline hydrochloride 0.05 g in 100 ml - purpose oxymetazoline hcl................ nasal decongestant uses - temporarily relieves nasal congestion due to:    • common cold    • hay fever    • upper respiratory allergies - temporarily relieves sinus congestion and pressure - shrinks swollen nasal membranes so you can breathe more freely

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

salado sales inc. - oxymetazoline hydrochloride (unii: k89mj0s5vy) (oxymetazoline - unii:8vln5b44zy) - oxymetazoline hydrochloride 0.05 g in 100 ml - purpose oxymetazoline hcl............... nasal decongestant uses  temporarily relieves nasal congestion due to:      common cold      hay fever      upper respiratory allergies  temporarily relieves sinus congestion and pressure  shrinks swollen nasal membranes so you can breathe more freely