> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Inaccurate Info in PediaCare Listings
- URL: https://www.fdaweb.com/inaccurate-info-in-pediacare-listings/
- Published: 2017-06-06T12:00:00.000Z
- Updated: 2026-09-14T22:27:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138861

FDA says its review of Prestige Brand Holdings’ listings for PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s Plus Flu products contain inaccurate information. An agency 6/1 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm561702.htm?ref=fdaweb.com) says the company must take prompt action to correct the deficiencies.

According to the letter, the active ingredient in the two drugs, phenylephrine hydrochloride appears on the copy of the label provided with the listing for each product, but is missing from the listing information in structured product labeling submitted for both drug listing files.

The firm was told to respond with a list of specific steps being taken to correct the violations with an explanation of what will done to prevent their recurrence, documentation of each step, and a timetable for completion.