Drugplain

ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1

Advil PM · TABLET, COATED · Lil Drug Store Products, Inc

No Recall History
Plain English

ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated is a tablet, coated containing advil pm at 38 mg/1, taken oral. Manufactured by Lil Drug Store Products, Inc.

Key Facts

Brand Name
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated
Generic Name
Advil PM
NDC Code (Product)
29485-6533
Manufacturer
Lil Drug Store Products, Inc
Strength
38 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
NDA021394
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
08/25/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,175 reports
somnolence424 reports
product use in unapproved indication346 reports
drug effective for unapproved indication283 reports
insomnia240 reports
feeling abnormal219 reports
fatigue180 reports
dizziness176 reports
intentional product misuse145 reports
headache116 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 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: 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 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

Frequently Asked Questions

What is ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated used for?

ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated contains Advil PM. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated a controlled substance?

ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated is not classified as a controlled substance by the DEA.

What is the generic name for ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated?

The generic name for ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated is Advil PM. There are no other listed brand versions of Advil PM.

What is the NDC code for ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1?

The NDC (National Drug Code) for ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1 is 29485-6533, listed by Lil Drug Store Products, Inc.

Product NDC

29485-6533

Package NDC

29485-6533-4

Other ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated Dosages

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

Data from openFDA · Public domain (CC0 1.0)