Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

A review of the listing for Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210, reveals that the strength of the active ingredient, doxylamine succinate, does not match between the labeling and the structured product labeling (SPL) sections of the listing submission. Specifically, in the labeling, the strength of the active ingredient, doxylamine succinate, is stated as 6.25 mg however, in the SPL’s basis of strength field, the strength of doxylamine succinate is listed as **(b)(4)**

Passage 2

Additionally, the name in the product listing does not match the name on the product labeling. Specifically, while the proprietary name on the principal display panel image is Maximum Strength Nighttime Severe Cold and Flu, in the listed name, the word “severe” is spelled as “sever.”