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Outline
What is the generic name?
HYDROCODONE BITARTRATE AND GUAIFENESIN
What is the Trade Name for HYDROCODONE BITARTRATE AND GUAIFENESIN?
OBREDON
What are the Indications for HYDROCODONE BITARTRATE AND GUAIFENESIN?
- 1 INDICATIONS AND USAGE OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with 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 less than 6 years of age [ see Contraindications ( 4 ) ]. Contraindicated in pediatric patients less than 6 years of age [ see Contraindications ( 4 ) ]. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1 ) ], reserve OBREDON 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. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1 ) ], reserve OBREDON 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. OBREDON is a combination of hydrocodone, an opioid agonist; and guaifenesin, an expectorant, indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older. ( 1 ) Important Limitations of Use: ( 1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OBREDON 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.
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References: https://open.fda.gov/
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