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Date: Jan. 10, 2024, 3:12 p.m.

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Date: 2024-01-11 08:40:20.000000

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Confirmation of Coldzep Tablet Formulation

Published by Department of Health(DOH) on Jan. 10, 2024.
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

B.ANG Jan. 10, 2024, 3:12 p.m.

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?

F.RECEIVING OFFICER Jan. 11, 2024, 8:40 a.m.

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

F.MAKER Jan. 11, 2024, 10:58 a.m.

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.

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