Active Ingredients (In Each Caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Dual Action With Acetaminophen (NDC 0573-0145). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, indications & usage, warnings, acetaminophen liver damage warning:, other, nsaid stomach bleeding warning, heart attack and stroke warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Uses
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in
pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of 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.
Directions
adults and children 12 years and over |
|
children under 12 years |
|
Other information
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide
Questions or comments?
call weekdays 9 AM to 5 PM at 1-800-88-ADVIL
NEW
Advil
DUAL ACTION
WITH Acetaminophen
BACK PAIN
Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
8 HOUR RELIEF
144
Caplets*
*Capsule-Shaped Tablets
000065288 Front Carton
* Please review the disclaimer below.