Drugplain

basic care ibuprofen pm 38 mg/1

diphenhydramine citrate, ibuprofen · TABLET, FILM COATED · Amazon.com Services LLC

No Recall History
Plain English

Basic Care Ibuprofen PM is an over-the-counter pain reliever and sleep aid tablet that combines ibuprofen (a nonsteroidal anti-inflammatory drug) with diphenhydramine citrate to help reduce minor aches and pains while promoting sleep. It is taken by mouth and is intended for temporary relief of minor pain associated with headaches, muscular aches, backache, minor arthritis pain, menstrual cramps, and the common cold.

Key Facts

Brand Name
basic care ibuprofen pm
Generic Name
diphenhydramine citrate, ibuprofen
NDC Code (Product)
72288-050
Manufacturer
Amazon.com Services LLC
Strength
38 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA079113
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
04/30/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective58 reports
off label use56 reports
underdose46 reports
product name confusion44 reports
somnolence35 reports
expired product administered32 reports
incorrect dose administered26 reports
accidental overdose21 reports
dizziness21 reports
wrong technique in product usage process21 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 Other information read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)

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.

Frequently Asked Questions

What is basic care ibuprofen pm used for?

Basic Care Ibuprofen PM is an over-the-counter pain reliever and sleep aid tablet that combines ibuprofen (a nonsteroidal anti-inflammatory drug) with diphenhydramine citrate to help reduce minor aches and pains while promoting sleep. It is taken by mouth and is intended for temporary relief of minor pain associated with headaches, muscular aches, backache, minor arthritis pain, menstrual cramps, and the common cold.

Is basic care ibuprofen pm a controlled substance?

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

What is the generic name for basic care ibuprofen pm?

The generic name for basic care ibuprofen pm is diphenhydramine citrate, ibuprofen. There are 12 other brand versions of diphenhydramine citrate, ibuprofen.

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

The NDC (National Drug Code) for basic care ibuprofen pm 38 mg/1 is 72288-050, listed by Amazon.com Services LLC.