The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS,  AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

BW

C

W

P

AR

Advil

Advil (200 mg ibuprofen) tablets [OTC]

Advil Allergy Sinus (2mg clorpheniramine maleate, 200 mg ibuprofen, and 30 mg pseudoephedrine HCl) tablets [OTC]

Advil Cold & Sinus (200 mg ibuprofen and 30 mg pseudoephedrine HCl) tablets [OTC]

Advil Cold & Sinus Liqui-Gels (200 mg ibuprofen and 30 mg pseudoephedrine HCl) capsules [OTC]

Advil Liquigels (200 mg ibuprofen) capsules [OTC]

Advil PM (200 mg ibuprofen/ 38 mg diphenhydramine citrate)tablets [OTC]

Advil PM Liqui-Gels (200 mg ibuprofen/ 25 mg diphenhydramine HCl) capsules [OTC]

Children’s Advil (100 mg/ 5 mL ibuprofen) Suspension [OTC]

Children’s Advil Chewables (50 mg ibuprofen) chewable tablets [OTC]

Children’s Advil Cold (100 mg ibuprofen and 15mg/5ml pseudoephedrine HCl) suspension [OTC]

Infant’s Advil (50 mg ibuprofen/ 1.25 mL) Concentrated Drops [OTC]

Junior Strength Advil (100 mg ibuprofen) tablets [OTC]

C

W

P

AR

BW

C

W

P

AR

BW

C

W

P

AR