Novis PR, Inc. recalls Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol
Novis PR recalls Pecgen DMX cough suppressant due to incorrect dosage instructions for children under 12. The label mistakenly states children 6-2 years should take 1 tsp every 4 hours, but it should be 6-12 years. Consumers should check labels for specific lot numbers and contact Novis PR for guidance.
Lower-risk recall
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Contact the company & request your remedy
What happened, in plain English
Novis PR is recalling Pecgen DMX cough suppressant because its label incorrectly states the safe dosage for children under 2 years old. This could lead to overdosing if parents follow the wrong instructions. The product has been found to have a typographical error in the dosage information. Read more at govinfonow.com/recall/38745-novis-pr-cough-suppressant-label-error-incorrect-dosage-for-young.
Source Summary by GovInfoNow · govinfonow.com/recall/38745-novis-pr-cough-suppressant-label-error-incorrect-dosage-for-young · Updated October 5, 2026 · FDA enforcement record: FDA #D-1395-2019
Cite this page
“Novis PR Cough Suppressant Label Error: Incorrect Dosage for Young Children.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38745-novis-pr-cough-suppressant-label-error-incorrect-dosage-for-young. Based on FDA recall #D-1395-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1395-2019%22&limit=1).
Why it’s dangerous
The product label incorrectly states that children aged 6 to under 2 years should take 1 teaspoon every 4 hours, which is not safe. The correct dosage should be for children 6 to under 12 years. The label also fails to advise consulting a doctor for children under 2 years.
Who’s affected
Parents and caregivers of children who use this cough suppressant are affected. Children under 2 years old are at higher risk due to the incorrect dosage instructions.
How to tell if you have this one
Check the label for the product name 'Pecgen DMX Cough Suppressant Expectorant' and lot numbers D80202, D80210 (expiring 02/20) or D80818, D80819, D80820 (expiring 09/20). The product is sold in 16 fl. oz. bottles with a cherry raspberry flavor.
- Brand
Novis PR- Category
Drug
What to do — step by step
Check Label
Look for the product name and lot numbers listed in the recall notice to confirm if your bottle is affected.
Questions people ask
Is this product safe for children under 2?
The label incorrectly states children 6 to under 2 years should take the product, but it should be 6 to under 12 years. The product is not safe for children under 2 without consulting a doctor.
How do I know if my bottle is recalled?
Check for lot numbers D80202, D80210 (expiring 02/20) or D80818, D80819, D80820 (expiring 09/20) on the label.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Novis PR directly for guidance.
Contact Novis PR
We’ve drafted a message you can send Novis PR to request your refund or repair — edit it as you like.
Subject: Recall D-1395-2019 — Novis PR Novis PR Hello, I own a Novis PR that is covered by recall D-1395-2019 from Novis PR. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1395-2019 (May 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1395-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.