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
2026-08-01
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/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:06:10

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.