FDA label 13d391cd-6737-4d5d-a811-4cd602ec0013

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
6a2c1efb-d91b-48d2-b623-aa941e2c6f0e
SPL ID
13d391cd-6737-4d5d-a811-4cd602ec0013
Version
1
Effective date
2010-06-15
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:01

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 Alcohol Warnings If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Do not use * with any other product containing acetaminophen * with any other product containing diphenhydramine, even one used on skin * in children under 12 years of age Ask a doctor before use if you have * a breathing problem such as emphysema or chronic bronchitis * glaucoma * difficulty in urination due to enlargement of the prostate gland ASK a doctor or pharmacists before use if you are taking sedatives or tranquilizers When using this product * do not exceed recommended dosage * avoid alcoholic beverages * marked drowsiness may occur * do not drive a motor vehicle or operate machinery Stop use and ask a doctor if * sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness * new symptoms occur * redness or swelling is present * pain gets worse or lasts more than 10 days * fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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