Active Ingredients (In Each Capsule)
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Pm (NDC 0573-0167). 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 capsule), purposes, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain reliever
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 during the last 3 months of 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.
D&C red no. 33, FD&C blue no. 1, medium-chain triglycerides, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution
Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL
For most recent product information, visit www.Advil.com
Distributed by: Pfizer, Madison, NJ 07940 USA
Advil® PM
LIQUI•GELS®
Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid
20
Liquid Filled
Capsules
Advil® PM
LIQUI•GELS®
Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid
80
Liquid Filled
Capsules
READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION
Great
Value
Advil®
PM
LIQUI•GELS®
Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid
80
Liquid Filled
Capsules
50%
MORE
FREE
10 Free
LIQUI•GELS®
Advil® PM
LIQUI•GELS®
Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid
30
Liquid Filled
Capsules
* Please review the disclaimer below.