Active Ingredient (In Each Capsule)
Diphenhydramine hydrochloride USP 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 Cvs Pharmacy for the product Ibuprofen Pm (NDC 69842-913). 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 USP 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 (1-800-222-1222) right away.
D&C red #33, FD&C blue #1, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbitan, sorbitol, titanium dioxide
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Compare to the active ingredients in Advil® PM†
Ibuprofen PM
IBUPROFEN, 200 mg
DIPHENHYDRAMINE HCl, 25 mg
Pain reliever (NSAID)
Nighttime sleep-aid
SOFTGELS**
**Liquid -illed capsules
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor Advil® PM.
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com 1-800-SHOP CVS
* Please review the disclaimer below.