Acetaminophen and Ibuprofen

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
Acetaminophen and Ibuprofen
Generic name
ACETAMINOPHEN AND IBUPROFEN
Manufacturer
RUGBY LABORATORIES
Product type
HUMAN OTC DRUG
SPL set ID
ed340993-04e6-b084-e053-2a95a90abf60
SPL ID
4653226b-ab67-b59c-e063-6294a90aa02a
Version
7
Effective date
2025-12-19
Source export date
2026-10-27
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/eeb012fd0992efa4f76b2aef09dd5f84150b96392c46717c44deabcc4e3581c1/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:41:23
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 2 · 5 matching rows.

warnings

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 6 caplets in 24 hours, which is the maximum daily amount for this product ■ 3 or more alcoholic drinks every day while using this product

warnings

Acetaminophen allergy alert: may cause severe skin reactions.Symptoms may include: ■ skin reddening ■ blisters ■ rash If skin reaction occurs, stop use and seek medical help right away.

warnings

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away.

warnings

NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

Reported adverse events (FAERS/openFDA)#

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