FDA label 46905178-dfa9-6110-e063-6294a90a62dc

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
4533925e-6542-4e58-91d6-8302039ec36f
SPL ID
46905178-dfa9-6110-e063-6294a90a62dc
Version
6
Effective date
2025-12-22
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:49

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

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take • More than directed • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product. Do not use: • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • with any other products containing diphenhydramine, even one used on skin • in children under 12 years of age Ask a doctor before use if you have: • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty or urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you: • are taking the blood thinning drug warfarin • are taking sedatives or tanquilizers When using this product: • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks Stop use and ask a doctor if: • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • new symptoms occur • redness or swelling is present • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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