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.
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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