Drugplain

Ibuprofen PM 38 mg/1

Diphenhydramine Citrate, Ibuprofen · TABLET, COATED · Safeway, Inc.

1 Recall on Record
Plain English

Ibuprofen PM is an over-the-counter oral tablet that combines ibuprofen, a nonsteroidal anti-inflammatory drug, with diphenhydramine citrate to help relieve pain and fever while promoting sleep. This combination medication is commonly used for nighttime pain relief when sleep disturbance is also a concern.

Key Facts

Brand Name
Ibuprofen PM
Generic Name
Diphenhydramine Citrate, Ibuprofen
NDC Code (Product)
21130-056
Manufacturer
Safeway, Inc.
Strength
38 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
ANDA211404
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
03/01/2024

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective59 reports
off label use57 reports
underdose46 reports
product name confusion44 reports
somnolence35 reports
expired product administered32 reports
incorrect dose administered26 reports
dizziness23 reports
wrong technique in product usage process23 reports
accidental overdose21 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

Dosage & Administration

Directions • do not take more than directed • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours

Warnings

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters 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 • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed 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. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after …

Frequently Asked Questions

What is Ibuprofen PM used for?

Ibuprofen PM is an over-the-counter oral tablet that combines ibuprofen, a nonsteroidal anti-inflammatory drug, with diphenhydramine citrate to help relieve pain and fever while promoting sleep. This combination medication is commonly used for nighttime pain relief when sleep disturbance is also a concern.

Is Ibuprofen PM a controlled substance?

Ibuprofen PM is not classified as a controlled substance by the DEA.

What is the generic name for Ibuprofen PM?

The generic name for Ibuprofen PM is Diphenhydramine Citrate, Ibuprofen. There are 9 other brand versions of Diphenhydramine Citrate, Ibuprofen.

What is the NDC code for Ibuprofen PM 38 mg/1?

The NDC (National Drug Code) for Ibuprofen PM 38 mg/1 is 21130-056, listed by Safeway, Inc..

Product NDC

21130-056

Package NDC

21130-056-40

Other Diphenhydramine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)