FDA label f8c91261-b067-4bea-810b-6b28dc893b0e

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
cb18f535-1876-4d1b-962a-a9fde8f180bb
SPL ID
f8c91261-b067-4bea-810b-6b28dc893b0e
Version
1
Effective date
2013-02-06
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:41:17

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children. Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 6 yrs. ask a doctor 6 to under 12 1-2 TSP or as directed by a doctor Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

warnings table

<table width="50%"> <col width="45%" align="center" valign="middle"/> <col width="55%" align="center" valign="middle"/> <thead> <tr styleCode="Botrule"> <th styleCode="Lrule Rrule">Age (yr)</th> <th styleCode="Rrule">Dose (TSP)</th> </tr> </thead> <tfoot> <tr> <td colspan="2" align="left">TSP = teaspoon</td> </tr> </tfoot> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">under 6 yrs.</td> <td styleCode="Rrule">ask a doctor</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">6 to under 12</td> <td styleCode="Rrule">1-2 TSP</td> </tr> <tr> <td colspan="2" styleCode="Lrule Rrule">or as directed by a doctor</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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