FDA label f16bbbd0-ac83-4274-8376-7f669c51ac63

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
dd45a89c-4ded-4710-8af3-047eeb26e0d2
SPL ID
f16bbbd0-ac83-4274-8376-7f669c51ac63
Version
2
Effective date
2015-05-04
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:00:50

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 with any other products containing diphenhydramine, including one applied topically Ask a Doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis, ■ glaucoma or ■ trouble urinating due to an enlarged prostate gland Ask a Doctor/Pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ marked drowsiness may occur ■ avoid alcoholic beverages ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Directions ■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours Adults and children 12 years of age and older 25 mg to 50 mg (1 to 2 caplets) Children 6 to under 12 years of age 12.5 mg** to 25 mg (1 caplet) Children under 6 years of age Consult a doctor ** A 12.5 mg dosage strength is not available in this package. (Do not attempt to break caplet) Other information ■ store at room temperature in a dry place ■ do not use if blister package is torn Inactive ingredients croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

warnings table

<table ID="inv-009bca68-bad3-40e6-8896-62419f2377d0" frame="border" border="1"> <col width="312px"/> <col width="276px"/> <thead valign="bottom"> <tr valign="bottom"> <td valign="bottom" styleCode="Botrule Lrule Rrule Toprule">Adults and children 12 years of age and older</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">25 mg to 50 mg (1 to 2 caplets)</td> </tr> </thead> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> Children 6 to under 12 years of age</td> <td styleCode="Botrule Rrule"> 12.5 mg** to 25 mg (1 caplet)</td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Children under 6 years of age</td> <td styleCode="Botrule Rrule"> Consult a doctor</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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