Drugplain

equaline ibuprofen pm 38 mg/1

diphenhydramine citrate, ibuprofen · TABLET, FILM COATED · United Natural Foods, Inc. dba UNFI

No Recall History
Plain English

Equaline Ibuprofen PM is an over-the-counter pain reliever and sleep aid that combines ibuprofen, a nonsteroidal anti-inflammatory drug, with diphenhydramine citrate to help reduce pain and promote sleep. It is taken by mouth as a film-coated tablet and is typically used for nighttime pain relief.

Key Facts

Brand Name
equaline ibuprofen pm
Generic Name
diphenhydramine citrate, ibuprofen
NDC Code (Product)
41163-050
Manufacturer
United Natural Foods, Inc. dba UNFI
Strength
38 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA079113
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
03/02/2009

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide5 reports
product use in unapproved indication4 reports
drug effective for unapproved indication3 reports
somnolence3 reports
toxicity to various agents2 reports
arthropathy1 reports
asthenia1 reports
balance disorder1 reports
bradycardia1 reports
cataract1 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 equaline ibuprofen pm used for?

Equaline Ibuprofen PM is an over-the-counter pain reliever and sleep aid that combines ibuprofen, a nonsteroidal anti-inflammatory drug, with diphenhydramine citrate to help reduce pain and promote sleep. It is taken by mouth as a film-coated tablet and is typically used for nighttime pain relief.

Is equaline ibuprofen pm a controlled substance?

equaline ibuprofen pm is not classified as a controlled substance by the DEA.

What is the generic name for equaline ibuprofen pm?

The generic name for equaline ibuprofen pm is diphenhydramine citrate, ibuprofen. There are 11 other brand versions of diphenhydramine citrate, ibuprofen.

What is the NDC code for equaline ibuprofen pm 38 mg/1?

The NDC (National Drug Code) for equaline ibuprofen pm 38 mg/1 is 41163-050, listed by United Natural Foods, Inc. dba UNFI.

Product NDC

41163-050

Package NDC

41163-050-27

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)