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Cough and Nasal Congestion Blog

Related terms: Cough and Blocked Nose

FDA Approves Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution

Posted 29 Jun 2011 by Drugs.com

MADISON, Miss.--(BUSINESS WIRE)--Jun 13, 2011 - Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII). The FDA also approved Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII). Both products are indicated for the relief of cough and symptoms associated with the common cold. Rezira and Zutripro Oral Solutions are the only FDA approved hydrocodone cough and cold combinations containing a nasal decongestant1. The approval of Rezira and Zutripro Oral Solutions marks the first NDA approval by the FDA for a liquid hydrocodone cough medication since 19901. These products will be marketed by Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical, Inc. "Currently, there are very few ... Read more

Related support groups: Cough and Nasal Congestion

FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution

Posted 29 Jun 2011 by Drugs.com

MADISON, Miss.--(BUSINESS WIRE)--Jun 13, 2011 - Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII). The FDA also approved Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII). Both products are indicated for the relief of cough and symptoms associated with the common cold. Zutripro and Rezira Oral Solutions are the only FDA approved hydrocodone cough and cold combinations containing a nasal decongestant1. The approval of Zutripro and Rezira Oral Solutions marks the first NDA approval by the FDA for a liquid hydrocodone cough medication since 19901. These products will be marketed by Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical, Inc. "Currently, there are very few ... Read more

Related support groups: Cough and Nasal Congestion

FDA Medwatch Alert: Cough and Cold Medications in Children Less Than Two Years of Age

Posted 17 Jan 2008 by Drugs.com

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this ... Read more

Related support groups: Cough, Cold Symptoms, Cough and Nasal Congestion, Common Cold

FDA Medwatch Alert: Nonprescription Cough and Cold Medicine Use in Children

Posted 15 Aug 2007 by Drugs.com

[Posted August 15, 2007] FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are ... Read more

Related support groups: Cough, Cold Symptoms, Cough and Nasal Congestion, Common Cold

FDA Medwatch Alert: Cough and Cold Medications in Children Less Than Two Years of Age

Posted 12 Jan 2007 by Drugs.com

[Posted 01/12/2007] The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years.[January 12, 2007- MMWR Weekly - CDC] Read more

Related support groups: Cough, Cold Symptoms, Cough and Nasal Congestion, Common Cold

FDA Medwatch Alert: WellPatch Cough & Cold Soothing Vapor Pads

Posted 19 Jul 2006 by Drugs.com

[Posted 08/01/2006] The Mentholatum Company and FDA notified consumers and healthcare professionals about a nationwide recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on it. This product contains camphor, eucalyptus oil, and menthol. Possible adverse events associated with chewing or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures.[August 01, 2006 - News Release - The Mentholatum Company] Read more

Related support groups: Cold Symptoms, Cough and Nasal Congestion, Common Cold

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Mucinex D, Alka-Seltzer, C-Phen DM, Bromfed DM, Daytime, Rondec-DM, C-Phen DM Drops, Vazotan, Zutripro, view more... 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Syrup, Robafen CF, DuraMAX, Aldex G, PDM GG, Atuss G, ExeTuss-DM, Nexphen PD, Deconex DM, Tusso-XR, Tusso-DM, Ambi 40 / 1000 / 60, Maxiphen-G DM, Duraphen Forte, Duraphen II DM, Dynex HD, Tussex, Tussafed-EX, Re-Tann, Hydro-Tuss XP, Sudex, Hytussin Expectorant, Drituss HD, Maxiphen, Extendryl G, GDP-EX, Dynex LA, Zotex LAX, Dacex-DM, Duraphen 1000, Dexcon-DM, Dexcon-PE, Anextuss, TriTuss, TriTuss-ER, Tussafed-EX Drops, Dacex-PE, Guaifen PE, D-Tann HC, Notuss-DC, Notuss-AC, Lohist-DM, Quintex, Vanacof DX, Despec NR Drops, Phenflu CD, Execof ER, Cotab AX, Maxiflu DM, Maxiphen CD, Maxiphen CDX, Sonahist-DM, Viravan-PDM, Vanatab DX, M-End PE, Coughtuss, Detuss, JayCof-HC, Zotex-D, Zotex-C, Tusnel-A, Aquatab C, Allres DS, Relahist-DM, Respa-PE, Cotab A, BroveX PSB DM, Duravent DPB, Extendryl GCP, BroveX PSE DM Tablets, BroveX PSE DM, PBM Allergy, Deconex IR, Poly-Vent IR, Z-tuss DM, Donatussin DM Drops, Donatussin DM Syrup, Codimal DH, Dexall, Nohist-DMX, Gilphex TR, Z-Tuss 2, Ala-Hist AC, 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Neo HC, Zotex-12D, PD-Cof, Quartuss DM, SudaTex-G, Zyrphen, PD-Cof Drops, CP Dec-DM Drops, Liquicough HC, DroTuss-CP, Dallergy DM, DM-PE-Chlor, Respi-Tann Pd, Maxifed-G, Tussi-12D, Maxiphen ADT, EndaCof-Plus, Hydex PD, Canges-HC, Sina-12X, Uni All 12, Relacon-HC, Maxi-Tuss HCX, Respi-Tann, Duotan DM, Levall-12, Bromatan-DM, DuraTan DM, Excof-SF, Codimal PH, Max HC, Broncotron-D, BromTann / DM Tann / PSE Tann, Tricof, Pancof, D-Tann CT, Dytan-CS, Ryna-12X, A-Tan 12X, Novahistine DH, Y-Cof DM, Pancof EXP, Ambi 5 / 15 / 100, Zotex, Levall 5.0, Mardrops-DX, Nucofed, Zotex Pediatric, Nortuss-DE, Levall, Gentex-LQ, ED DM, Ricotuss, Sinutuss DM, DMax, Duraflu, Hydro-DP, Trituss-A, Rindal HPD, Albatussin Pediatric, Hydro-Tussin EXP, DMax Pediatric, Pedia Relief Infant, Brovex HC, Histinex PV, Pediatex HC, Tussend, BetaTan, VasoTuss HC, KG-Dal HD, Tuss-PD, Endotuss-HD, Ditussin-HC, Chemtussin HC, Hyphen-HD, Cyndal HD, Nasatuss, Chemdal HD Plus, Iotussin HC, Chlorgest HD, Ed-Tuss HC, Exo-Tuss, Endal-HD Plus, Uni Tuss HC, Highland HC, H-C Tussive, Histussin-HC, Cytuss HC, KG-Dal HD Plus, Maxi-Tuss HC, Comtussin HC, Enplus-HD, Tuss-HC, Ventuss Syrup, Maxi-Tuss SA, Vanex-HD, Guiaphen HD, P-V Tussin, Tussgen, Hytussin, Iotussin D Liquid, Histinex D, Tussafin, Nucodine, Carbatab-12, SymTan A, Oratuss 12, KG-Fed, Cycofed, Entuss-D Liquid, H-C Tussive D, Iodal HD, Chemdal HD, Rindal-HD, Ed-TLC, Efasin-HD, Endagen-HD, Tricodene Sugar Free, Pancof HC, SymTan, Vicks 44D, Primatuss 4, Alacol DM, QC Cough / Cold, dexchlorpheniramine / dextromethorphan / phenylephrine / pyrilamine, dexchlorpheniramine / dextromethorphan / phenylephrine, dexchlorpheniramine / hydrocodone / phenylephrine, dextromethorphan / diphenhydramine / phenylephrine, dextromethorphan / guaifenesin / phenylephrine, dexbrompheniramine / hydrocodone / phenylephrine, dexbrompheniramine / dextromethorphan / phenylephrine / pyrilamine, codeine / phenylephrine / pyrilamine, chlorpheniramine / hydrocodone / pseudoephedrine, codeine / pseudoephedrine, codeine / pseudoephedrine / triprolidine, dexbrompheniramine / dextromethorphan / phenylephrine, dextromethorphan / guaifenesin / potassium guaiacolsulfonate, dextromethorphan / guaifenesin / pseudoephedrine, hydrocodone / pseudoephedrine / triprolidine, hydrocodone / pseudoephedrine, codeine / guaifenesin / phenylephrine, acetaminophen / codeine / guaifenesin / phenylephrine, brompheniramine / dihydrocodeine / pseudoephedrine, guaifenesin / phenylephrine / pyrilamine, guaifenesin / hydrocodone / pseudoephedrine, dextromethorphan / pseudoephedrine, dextromethorphan / phenylephrine, dihydrocodeine / guaifenesin / pseudoephedrine, diphenhydramine / hydrocodone / phenylephrine, guaifenesin / hydrocodone / phenylephrine, chlorpheniramine / hydrocodone / phenylephrine, chlorpheniramine / dihydrocodeine / pseudoephedrine, brompheniramine / dextromethorphan / phenylephrine, brompheniramine / dextromethorphan / guaifenesin / phenylephrine, brompheniramine / dextromethorphan / pseudoephedrine, brompheniramine / hydrocodone / phenylephrine, brompheniramine / hydrocodone / pseudoephedrine, brompheniramine / carbetapentane / phenylephrine, acetaminophen / guaifenesin / phenylephrine, acetaminophen / dextromethorphan / doxylamine / phenylephrine, acetaminophen / chlorpheniramine / dextromethorphan / phenylephrine, acetaminophen / dextromethorphan / guaifenesin / pseudoephedrine, acetaminophen / dextromethorphan / phenylephrine, acetaminophen / dextromethorphan / pseudoephedrine / pyrilamine, carbetapentane / diphenhydramine, carbetapentane / diphenhydramine / phenylephrine, chlorpheniramine / dextromethorphan / guaifenesin / phenylephrine, chlorpheniramine / codeine, chlorpheniramine / dextromethorphan / phenylephrine, chlorpheniramine / dextromethorphan / pseudoephedrine, chlorpheniramine / dihydrocodeine / phenylephrine, carbinoxamine / hydrocodone / phenylephrine, carbinoxamine / dextromethorphan / phenylephrine, carbetapentane / guaifenesin / phenylephrine, carbetapentane / phenylephrine, carbetapentane / phenylephrine / pyrilamine, carbetapentane / pseudoephedrine, acetaminophen / chlorpheniramine / codeine, acetaminophen / codeine / guaifenesin / pseudoephedrine, brompheniramine / chlophedianol / phenylephrine, chlophedianol / phenylephrine / pyrilamine, Detussin, Histussin D, Lortuss HC, chlophedianol / chlorcyclizine systemic, chlophedianol / chlorcyclizine / pseudoephedrine, doxylamine / pseudoephedrine, dextromethorphan / doxylamine / pseudoephedrine, codeine / dexbrompheniramine / pseudoephedrine, dexbrompheniramine / dextromethorphan / pseudoephedrine, chlophedianol / guaifenesin / phenylephrine, Nalex CR, Mardrops-EX, Genelan NF, Zotex-GP, Zotex-DM, Scot-Tussin DM, Tricodene SF, Gentex LA, Guaphenyl LA, Congestac, Lusonex, Miraphen PE, Rescon-GG, chlophedianol / phenylephrine / triprolidine, chlorcyclizine / codeine / phenylephrine, dextromethorphan / pseudoephedrine / pyrilamine, chlophedianol / guaifenesin / pseudoephedrine, carbetapentane / pyrilamine, chlorpheniramine / dextromethorphan / guaifenesin / methscopolamine / phenylephrine, dextromethorphan / doxylamine, chlophedianol / dexchlorpheniramine / pseudoephedrine, codeine / dexchlorpheniramine / phenylephrine, brompheniramine / dihydrocodeine / phenylephrine, brompheniramine / codeine / phenylephrine, chlorpheniramine / guaifenesin / hydrocodone / pseudoephedrine, codeine / phenylephrine, dihydrocodeine / phenylephrine, aspirin / dextromethorphan / phenylephrine, aspirin / dextromethorphan / doxylamine / phenylephrine, chlophedianol / dexbrompheniramine / phenylephrine, carbetapentane / guaifenesin / pseudoephedrine, chlophedianol / pseudoephedrine, codeine / pseudoephedrine / pyrilamine, carbetapentane / dexchlorpheniramine / phenylephrine, brompheniramine / codeine / pseudoephedrine, dihydrocodeine / phenylephrine / pyrilamine, aspirin / chlorpheniramine / dextromethorphan / phenylephrine, codeine / diphenhydramine / phenylephrine, carbetapentane / pseudoephedrine / pyrilamine, carbetapentane / phenylephrine / potassium guaiacolsulfonate, Tuss-DS, Efasin-HD Plus, Guaitab, Guaifenex RX, Biotuss PE, Guiatuss PE, Mastussin PE, Ru Tuss DE, Zaptec PSE, Guaipax PSE, Guai Sudo, Iotex PSE, Ami-Tex PSE, Pseudo-G / PSI, Mytussin PE, Q-Tussin PE, Guaivent (Ethex), Robafen PE, Altarussin PE, Sudafed Non Drying Sinus, Sinutab Non Drying, Degen II, Venbid TR, T-Tussin PE, Robichem PE, Tusscidin PE, Tussin PE, Sinufed, Guiatex PSE, Hi Tex PSE, Deconsal LA, V-Dec-M, D-Feda II, Guaifenex PSE 60, Demibid II, Stamoist E, Tuss-LA, Pseudocot-G, Guaibid D Pediatric, Nasatab LA, Eudal SR, Sudal 60 / 500, Guiadrine II, Iosal II, Guaifed-PSE, GP 500, Abletex-PSE, Guiadrine PSE 120, Guai-Vent / PSE, Deco-D, Desal II, Guiatex II, Guiadrine II SR, Defen-LA, Decongest II, Uni Tussin PE, Humibid GC, Sinupan, Ru-Tuss Jr, Deconsal Pediatric, Efasin, Amidal, Pseudo GG TR, acetaminophen / caffeine / chlorpheniramine / hydrocodone / 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Promethazine VC with Codeine, M-Phen, B-Tuss, Tussive HC, Hydro-PC II, Hydron CP, De-Chlor HD, Hydrocodone CP, Liquitussin HC Syrup, Quindal HD, Quindal HD Plus, Hi-Tuss HC, Chlorphen HD, Duradal HD, De-Chlor HC, Atuss MS, Tusana-D, Relacon-HC NR, Poly-Tussin HD, Relasin-HC, Z-Cof HC, Phendal-HD, Echotuss-HC, Hydro-PC II Plus, Triant-HC, Uni-Tricof HC, Rindal HD Plus, Cerose DM, Tussar DM, Atuss-12 DM, M-End DM, Dicel DM, Atuss DS, Guaimax-D, C-Phed DM, Tanafed-DM, Creomulsion Pediatric, Vicks 44M Pediatric, Kidcare Cough and Cold, Childrens NyQuil, Rescon-DM, Anatuss LA, Fenex-PSE, Guaifed, Guaibid D, Nalex Jr, G-Phed- PD, Sinufed Timecelles, Respaire-120 SR, G-Phed, Syn-Rx, Rymed, Respaire-60 SR, Nasabid, Rhinosyn-DM, Sildec-PE DM, Uni-Tuss DM, Corfen-DM, Mintuss DR, P Chlor DM, Dex PC, Atuss DR, Tri-Vent DPC, Norel DM, Liquituss R-DM, De-Chlor DM, De-Chlor DR, Coldtuss-DR, Donatussin DM, Ceron-DM Drops, Cardec DM Drops, Neo DM Drops, Reme Tussin DM, Tussplex DM, Sildec-PE DM Drops, CP Dec DM, HistadecDM, Rondex-DM, Rondex-DM Drops, Dec-Chlorphen DM, Dec-Chlorphen DM Drops, Guaifed Caps