Dologesic DF

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 DF
Generic name
ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Manufacturer
Llorens Pharmaceutical International Division
Product type
HUMAN OTC DRUG
SPL set ID
55768b45-fd98-4779-85b6-6a50c628677e
SPL ID
47460679-895e-b4d5-e063-6394a90ab919
Version
7
Effective date
2025-12-31
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:57:24
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 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 Allergy Alert: Acetaminophen may cause sever skin reactions. Symptoms may incloude skin reddening blister rash. If a skin reaction occurs, stop and seek medical help right away. While using this product drosiness may occur;alcohol, sedatives, and tranquilizers may increase drowsiness effect avoid alcoholic beverages do not take this product if you are taking sedatives or transquilizers without consulting your doctor use caution when driving a 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.