boxed warning
Tamper Evident Feature: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.
FDA label 6e48cc89-a67d-4ca5-a5a2-b0bba161f113
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
- SPL set ID
- 316ff3d0-b6f0-4565-ad88-de0b5be5a98b
- SPL ID
- 6e48cc89-a67d-4ca5-a5a2-b0bba161f113
- Version
- 2
- Effective date
- 2011-10-27
- Source export date
- 2026-09-28
- 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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:13:38
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 6e48cc89-a67d-4ca5-a5a2-b0bba161f113 | id | |
| spl set id | 316ff3d0-b6f0-4565-ad88-de0b5be5a98b | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. (Original Formula) In case of accidental overdose, get medical help or contact a Poison Control Center right away. Overdose warning: (Maximum Strength) 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.