FDA label 41e7b830-3a09-4c6b-9efd-ab8044fb8ced

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)

SPL set ID
e7242fda-59d6-4abf-b1ec-0d91549a613e
SPL ID
41e7b830-3a09-4c6b-9efd-ab8044fb8ced
Version
2
Effective date
2017-11-04
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:20

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

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. • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if the child has • high blood pressure • thyroid disease • glaucoma • diabetes • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis • cough that lasts or is chronic such as occurs with asthma • heart disease Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • do not exceed recommended dosage • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occurs • symptoms do not get better within 7 days or occur with fever • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. A persistent cough may be a sign of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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