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Cough and Nasal Congestion Blog

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Blog (6)

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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