FDA-Drug2013-03-06Class III
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.
Bayer Healthcare, LLC
Hazard
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Sold states
Nationwide
Affected count
1,353,420 Blister Packs
Manufactured in
36 Columbia Rd, N/A, Morristown, NJ, United States
Products
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-177-2013Don't want to check this manually?
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