Defensol-ito

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Defensol-ito
Generic name
DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE
Manufacturer
Menper Distributors, Inc
Product type
HUMAN OTC DRUG
SPL set ID
a7c7a60d-d49f-4239-92f7-714eac7eb0c5
SPL ID
3a8ae61d-30c1-903c-e063-6394a90ae5c2
Version
8
Effective date
2025-07-22
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:13
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has heart disease thyroid disease cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with asthma high blood pressure diabetes When using this product, do not use more than directed Stop use and ask doctor if your child gets nervous, dizzy, or sleepless symptoms do not get better within 7 days, comes back, or is accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.