ACTINEL DM Pediatric

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
ACTINEL DM Pediatric
Generic name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
ACTIPHARMA, LLC
Product type
HUMAN OTC DRUG
SPL set ID
f85d8586-423f-48a3-9bb2-bbc5984c7cd3
SPL ID
e0485b3d-5021-4c2e-aa88-b10bcc2511a5
Version
1
Effective date
2026-01-15
Source export date
2026-11-06
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:16:28
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use in a 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 • high blood pressure • thyroid disease • diabetes • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough such occurs with asthma When using this product • do not exceed recommended dosage Stop use and ask a doctor if • your child gets nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition. Keep out of reach of children . In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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