Active Ingredient (In Each Capsule)
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*non-steroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Ibuprofen Pm (NDC 36800-756). 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 ingredient (in each capsule), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, 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)
*non-steroidal anti-inflammatory drug
Nighttime sleep-aid
Pain Reliever
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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning: 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 (1-800-222-1222).
D&C red #33, FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol
Call toll free 1-888-423-0139
COMPARE TO ADVIL®PM LIQUI-GELS® ACTIVE INGREDIENTS†
NIGHTTIME
Ibuprofen PM Capsules
PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID
IBUPROFEN & DIPHENHYDRAMINE HCI 200 mg/25mg
SOFTGELS**
**Liquid-Filled Capsules
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Liqui-Gels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO PLVA0318
* Please review the disclaimer below.