FDA label 1985c7d9-b29d-49a3-92f3-653a929fa559

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
c8dbe8d6-8816-4aee-a9e1-035a04aa3666
SPL ID
1985c7d9-b29d-49a3-92f3-653a929fa559
Version
13
Effective date
2016-11-08
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:33

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 with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma cough accompanied by excessive phlegm (mucus) breathing problems such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Reported adverse events (FAERS/openFDA)#

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