Dologesic NF

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)

Brand name
Dologesic NF
Generic name
ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Manufacturer
Llorens Pharmaceutical International Division
Product type
HUMAN OTC DRUG
SPL set ID
974fc0d5-7a99-46fb-af38-b91240f728fa
SPL ID
47460679-895d-b4d5-e063-6394a90ab919
Version
8
Effective date
2025-12-31
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:54:59
Harmonized routes table
Harmonized routes
ORAL

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 Warning : If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 8 capsules in 24 hours, which is the maximum daily amount with other drugs containing acetaminphen 3 or more alcoholic drinks every day while using this product May cause drowsiness:: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor. Use caution when driving motor vehicle or operating machinery Do not use with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen ask a doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in the product for more than 10 days for pain, unless directed by a doctor for more than 3 days for fever, unless directed by a doctor Ask a doctor before use: if you have liver disease if you are taking the blood thinning drug warafin Stop using this product and ask a doctor if: pain gets worse or last more than 10 days fever gets worse or last more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition

Reported adverse events (FAERS/openFDA)#

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