Details for: COUGH SYRUP WITH CODEINE


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Product description

Product name: COUGH SYRUP WITH CODEINE

Company name: TEVA CANADA LIMITED

DIN: 02099748

Status: Marketed

Status date: 2013-04-23

Active ingredient(s) Strength
CODEINE PHOSPHATE 3.3 MG / 5 ML
GUAIFENESIN 100 MG / 5 ML
PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG / 5 ML

Resources

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For consumers
Resource Description
Summary Safety Review - Prescription Opioids (buprenorphine, butorphanol, codeine, diamorphine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, nalbuphine, normethadone, oxycodone, tapentadol and tramadol) - Assessing the Potential Risk of Esophageal Dysfunction With Long-term Use

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Report a side effect

Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.

All suspected side effects should be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
  • Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
  • Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
For health care professionals
Resource Description
Summary Safety Review - Prescription Opioids (buprenorphine, butorphanol, codeine, diamorphine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, nalbuphine, normethadone, oxycodone, tapentadol and tramadol) - Assessing the Potential Risk of Esophageal Dysfunction With Long-term Use

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Report a serious adverse drug reaction (for hospitals)

Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.

This regulatory requirement only applies to hospitals.
For researchers
Resource Description
Search Clinical Information After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes.
All resources
Resource Description
Summary Safety Review - Prescription Opioids (buprenorphine, butorphanol, codeine, diamorphine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, nalbuphine, normethadone, oxycodone, tapentadol and tramadol) - Assessing the Potential Risk of Esophageal Dysfunction With Long-term Use

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Search Clinical Information After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes.
Report a side effect

Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.

All suspected side effects should be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
  • Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
  • Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
Report a serious adverse drug reaction (for hospitals)

Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.

This regulatory requirement only applies to hospitals.
Resource Description
Summary Safety Review - Prescription Opioids (buprenorphine, butorphanol, codeine, diamorphine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, nalbuphine, normethadone, oxycodone, tapentadol and tramadol) - Assessing the Potential Risk of Esophageal Dysfunction With Long-term Use

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Report a side effect

Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.

All suspected side effects should be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
  • Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
  • Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
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