Requested from DOH by B. Ang at 03:12 PM on
Jan 10, 2024.
Purpose: Medication Safety and Patient Care
Date of Coverage: 01/10/2024 - 01/10/2024
Tracking no: #DOH-394477885122
Ang 03:12 PM, Jan 10, 2024
I would like to inquire about the product formulation of Coldzep Tablet if the contents are true.
I have observed that the product, Coldzep, contains 25mg of Phenylephrine. However, I could not find any clinical evidence which supports the dosage of Phenylephrine at 25mg.
I could only find clinical references about Phenylephrine being formulated at 10mg or Phenylpropanolamine (PPA), which is a different Active Ingredient for Nasal Congestion, at 25mg.
Is Coldzep mislabeled? Or is the dosage strength intentional?
Receiving Officer 08:40 AM, Jan 11, 2024
January 11, 2024
Dear Benedict Dior,
Thank you for your request dated Jan 10, 2024 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Confirmation of Coldzep Tablet Formulation.
We received your request on Jan 10, 2024 and will respond on or before Jan 31, 2024 03:12:55 PM, in accordance with the Executive Order's implementing rules and regulations.
Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0zOTQ0Nzc4ODUxMjIM, for request with ticket number #DOH-394477885122.
Thank you.
Respectfully,
FOI Receiving Officer
FOI Officer
Maker 10:58 AM, Jan 11, 2024
Good day!
Please be informed that we have endorsed your request to the Food and Drug Administration (FDA) for action. We'll send you feedback once available.
Thank you.
Maker 02:02 PM, Jan 25, 2024
January 25, 2024
Dear Benedict Dior Ang,
I refer to my letter of Jan 10, 2024 03:12:55 PM; about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Confirmation of Coldzep Tablet Formulation.
Our response to your request is due on Jan 31, 2024 03:12:55 PM. Unfortunately, it is taking longer than expected to deal with your request because we are still awaiting for the response from FDA
I apologize for this delay but have applied for an extension so we could work further on your request. We hope to be able to send you a response on or before Feb 28, 2024 03:12:55 PM.
Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0zOTQ0Nzc4ODUxMjIM, for request with ticket number #DOH-394477885122.
Thank you.
Respectfully,
FOI Decision Maker
FOI Officer
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