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

amneal pharmaceuticals llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride oral solution, usp is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi).

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

akorn - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi).

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

nostrum laboratories, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and codeine phosphate oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. - contraindicated in pediatric patients under 12 years of age [see contraindications (4) and use in specific populations (8.4) ]. - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see contraindications (4) and use in specific populations (8.4) ]. - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve promethazine hydrochloride and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outw

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

preferred pharmaceuticals, inc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use promethazine with codeine oral solution is contraindicated for: promethazine with codeine oral solution is also contraindicated in patients with: risk summary promethazine with codeine oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.19) and clinical considerations ]. there are no available data with promethazine with codeine oral solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with codeine have reported inconsistent findings and have important methodological limitations (see data ). there are reports of respiratory depression when codei

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

par pharmaceutical - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. - contraindicated in pediatric patients under 12 years of age [see contraindications (4) and use in specific populations (8.4) ]. - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy and/or adenoidectomy [see contraindications (4) and use in specific populations (8.4) ]. - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve promethazine with codeine oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. promethazine with c

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

cardinal health - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg - promethazine hydrochloride, is useful orally for: perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of post-operative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hydrochloride tablets, usp are contraindicated for use

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

nucare pharmaceuticals,inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. the combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. codeine sulfate is contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. (see warnings - death related to ultra- rapid metabolism of codeine to morphine ). codeine is contraindicated in patients with a known hypersensitivity to the drug. promethazine hydrochloride is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. prometha

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

h.j. harkins company, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg - promethazine hydrochloride, is useful orally for. perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of post-operative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hydrochloride tablets, usp are contraindicated for use

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

proficient rx lp - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. the combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.  codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. codeine is contraindicated in patients with a known hypersensitivity to the drug. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.   promethazine hydrochloride and codeine phosphate syrup is a schedule v controlled s

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

zydus pharmaceuticals usa inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 12.5 mg - promethazine hydrochloride, is useful orally for. perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of post-operative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hydrochloride tablets, usp are contraindicated for use