FDA label c3298322-a795-4cbf-99c7-d2e644e3acae

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
0f0b5330-7e97-489f-a0c7-54f68f6675ce
SPL ID
c3298322-a795-4cbf-99c7-d2e644e3acae
Version
12
Effective date
2021-01-25
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:14

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 DAYTIME In a child under 4 years of age 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. NIGHTTIME in a child under 4 years of age in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs 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 for the purpose of making your child sleepy Ask a doctor before use if the child has DAYTIME heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma NIGHTTIME heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma a breathing problem such as chronic bronchitis Ask a doctor or pharmacist before use if the child is NIGHTTIME taking sedatives or tranquilizers. When using this product DAYTIME do not use more than directed. NIGHTTIME do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. NIGHTTIME nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition. Keep out of reach of children. DAYTIME In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. NIGHTTIME In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Reported adverse events (FAERS/openFDA)#

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