Bayer de Mexico, S.A. de C.V. · 66-41 · MEXICO
For Bayer de Mexico, S.A. de C.V., import alert is 66-41; country is MEXICO; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief); product code is 60 C - - 09 Phenylephrine HCl (Adrenergic) | 60 S - - 99 Antacid, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic); date published is 09/17/2014; address is Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO, verified against its source on 2026-10-01.
- Firm
- Bayer de Mexico, S.A. de C.V. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- MEXICO verified
- Address
- Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO verified
- Date published
- 09/17/2014 verified
- Product code
- 60 C - - 09 Phenylephrine HCl (Adrenergic) | 60 S - - 99 Antacid, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) each item verified
- Product
- Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) each item verified
- FDA notes
- The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. | The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. | The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. each item verified
What the source says
Bayer de Mexico, S.A. de C.V. Date Published : 09/17/2014 Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
60 C - - 09 Phenylephrine HCl (Adrenergic) Date Published: 09/17/2014 Desc: Tabcin Effervescent Tablets (Cold and flu relief) Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. 60 S - - 99 Antacid, N.E.C. Date Published: 09/17/2014 Desc: Tabcin Effervescent Tablets (Cold and flu relief) Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) Date Published: 09/17/2014 Desc: Tabcin Effervescent Tablets (Cold and flu relief) Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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